FSIS Policy Memoranda Table of Contents

PM.No. 001 002 003 004A 005A 006 007 008 009 010 011 012 013 014 015A 016B 017 018A 019B 020A 021 022C 023 024 025 026 027 028 029 030A 031A 032 033 034 035 036 037 038 039

Subject Pizza Containing Cheese Substitutes Butifarra Sausage Reduced Price or Money Savings Claims Sweet Red Peppers and Pimientos Labeling of Certain Cooked Sausage Products Containing Both Livestock and Poultry Ingredients Poultry Salami Products Rescinded Rescinded Rescinded Label Approval Guidelines for Sausages Containing Cheese Label Approval Guidelines for Sausages and Pudding Containing Potatoes Uncooked Meat and Poultry Teriyaki Chili Verde and Chili Colorado Handling Statements in Addition to the Requirements of 9 CFR 317.2(k) & 9 CFR 381.125 Sausage Product Labeled "Linguica" Combinations of Ground Beef or Hamburger and Soy Products Potassium Sorbate Dual Weight Requirement for Stuffed Poultry Labels Negative Ingredient Labeling Labeling of Cooked Mettwurst Sausage Products Labeled "Longaniza" and "Longaniza Puerto Rican Style" Rescinded Labeling of Boneless Ham Products Rescinded Rescinded Rescinded Clarification of "Meat" Definition in Chopped Beef, Ground Beef or Hamburger Rescinded Labeling Poultry Products Containing Livestock Ingredients Labeling Meat Products Containing Poultry Ingredients "Cooked Salami" Labeling Raw Poultry Meat (9 CFR 381.117(b) Labeling of Cured Meat Products Fresh Chorizos High Fructose Corn Syrup (HFCS) in Meat or Poultry Products Plastic Cans Alternate Principal Display Panels Labeling Cured Products as "Honey Cured", "Sugar Cured" or "Honey and Sugar Cured" Rescinded

040 041B

042 043 044A 045 047 048 050B 051 052 053 054 055 056 057A 058A 059 060 061A 062 063A 064 065 066C 067 068 069 070C 071B 072 073 074 075 076 077 078A 079 080 081A 082 083A 084A 085 086A

Smoked Products Labeling of Boneless Ham Products, Whole Muscle Roast Beef Products, and Boneless Poultry Products (Except Turkey Ham (9 CFR 381.171) Containing Ground and/or Emulsified Trimmings Raw Bone-in Poultry Products Containing Solutions Rescinded Raw Boneless Poultry Containing Solutions Product Names of Margarine Substitutes Net Weight Statements on Packages with Header Labels Level of Beef in Berliner Canadian Style Bacon Species Sausage The Use of Cured Pork Tissue in Making Lard Rescinded Quality Control Claims Rescinded Potassium Sorbate and Propylparaben on Semi-dry Sausage Labeling Turkey Ham Products Containing Added Water Smoked Products Labeling Turkey Ham Products Containing Ground Turkey Thigh Meat Rescinded Corn Dogs Rescinded Labeling Requirements for Products Labeled as "Uncured" Rescinded Rescinded Uncooked Red Meat Products Containing Added Substances Rescinded Requirements for the Use of Geographic and Related Terms on Product Labels Labeling for Substitute Products Rescinded Rescinded Composite Ingredients Statements Rescinded Rescinded Dual Inspection Legends on Product Containers Standards and Labeling Requirements for Duck Liver and/or Goose Liver "Foie Gras" Products Labeling and Standards Requirements for Quiche Products Rescinded Rescinded Rescinded Rescindment of Policy Memo 081 (Permitted Processing Procedures for Marinated Products) Labeling of Institutional and Wholesale Type, Large, Immediate Containers Check-off Blocks on Labeling Cooked Red Meat Products Containing Added Substances Rescinded Rescinded

087A 088 089 090B 091 092 093 094B 095 096 097 098B 099 100 101A 102 103 104 105 106A 107 108B 109 110 111 112 113 114A 115 116 117 118 119 120 121B

122 123 124

Word Size in Labeling of Product Names and Fanciful Names Labeling of Meat and/or Poultry Products with the Term Nuggets Use of the Term Breaded on Labels for Fritters Protective Coverings Ground Beef Chuck and Ground Beef Round Veal Parmigiana Made with Veal Patties Adjusting for Protein Fat Free (PFF) Controlled Pork Sulfiting Agents in Meat and Poultry Food Products Colored Casings-labeling of Meat and Poultry Products Rescinded Label Approval Guidelines for Wild Boar Products Labeling and Use of Beef Cheek Meat and Beef Head Meat, and Pork Cheek Meat and Pork Head Meat Labeling of Products Which Include Packets of Other Components Poultry Tenders and Poultry Tenderloins Use of Quality Grade Terms and Subjective Terms on Labels The Labeling of Products Containing Meat with Added Solutions or Other Nonmeat Ingredients in Secondary Products Boneless, Raw, or Cooked, Poultry Containing Binders Handling Statements on Retorted Products Labeling Requirements for Pump-cured Bacon Products Treated with D-or-dl-alpha-tocopherol in Surface Applications Poultry Bacon Use of "New" and Similar Terms Water-misted and Ice-glazed Meat and Poultry Products Labeling Prominence Guidelines for Cured, Cooked Products with Added Substances That Do Not Return to Green Weight Perishable, Uncured Meat and Poultry Products in Hermetically Sealed Containers Labeling of Meat and Poultry Stick Items Caramel Coloring Labeling of Products Which Are Artificially Colored Point of Purchase Materials Rescinded Canadian Style Bacon Made With/from Pork Sirloin Hips Smoked Flavoring Use of the Terms "Extra" and "More Than" Labeling of Safe Thawing Instructions on Consumer Packages Sausage Type Products with Fruits and Vegetables Labeling of Modified, Substitute Versions of Fresh (Species) Sausage, Hamburger, or Ground Beef Products with Added Ingredients Used to Replace Fat That Qualify for Use of Certain Nutrient Content Claims Associated with a Reduction in Fat Content Meat Content Requirements for Meat Soup Modified Breakfast Sausage, Cooked Sausage, and Fermented Sausage Products Identified by a Nutrient Content Claim and a Standardized or Traditional Name Declaration of Net Quantity of Contents on Combination Packages Containing Liquid and Solid Products

To: Branch Chiefs

Policy Memo 001 May 6, 1980

From: Robert G. Hibbert, Acting Director, MPSLD Subject: Pizzas Containing Cheese Substitutes (9 CFR 319.600)

ISSUE: Appropriate labeling requirement for pizza products containing both cheese and cheese substitutes. POLICY: Labels which contain cheese in a ratio of at least one part per nine parts cheese substitute and which otherwise comply with the requirements of the standard may be approved. Labels of product with cheese in smaller amounts must contain additional qualifying information. BASIS: The current regulation specifies cheese as a necessary characterizing ingredient in product to be labeled pizza. It does not specify percentages nor does it address questions regarding the use of cheese substitutes. Informal policy has evolved which has permitted label approvals without qualifying information, as long as the product contains some cheese, but concerns have developed that consumers might be misled by labels of products in which the actual cheese content is very low. These issues may not be fully resolved until the completion of pending rulemaking. Nevertheless an interim policy decision is necessary to assure that product is not misbranded. This policy should assure that the product is sufficiently characterized by cheese ingredient without imposing any substantial burden upon those who have relied on the policy as it has developed to date.

To: Branch Chiefs

Policy Memo 002 May 30, 1980

From: Robert G. Hibbert, Acting Director, MPSLD

Subject: Butifarra-Sausage (319.140 - 319.141)

ISSUE: Appropriate labeling for sausage product featuring the term "Butifarra"
POLICY: Labeling that features the term "Butifarra" would require in addition one of the following products:
Pork Sausage - for those products that meet the fresh pork sausage standard.
Fresh Sausage - for those products that include by-product but do not meet the standard for pork sausage.
Sausage - for those products that are incubated or fermented.
The term "Puertorrican Style" would be applicable if manufactured in Puerto Rico. Other label applications
will be considered on an individual basis.
BASIS: To the best of our knowledge the English translation of Butifarra is Sausage.
Information from inspection located in Puerto Rico indicates that Butifarra is historically an uncured sausage
made in several different ways according to the locality.

To: Branch Chiefs

Policy Memo 003 June 10, 1980

From: Robert G. Hibbert Acting Director MPSLD Subject: Reduced Price or Money Saving Claims ISSUE: Guidelines for approval of these claims. POLICY: Claims suggesting or stating that a product or a line of products are being sold at a price that is less than the customary or ordinary price for that product or similar products may be used under the following conditions: The company initiating the claims must be capable, upon request, of verifying that the cost of the product to the retailer has been reduced sufficiently to enable the retailer to pass the price reduction on to the consumer. This may entail the keeping, maintaining, or securing of invoices and other records through all levels of commerce. A company unable to produce sufficient verification upon request or a company identified by an inspector in charge of not fulfilling the claims stated will have all such labels rescinded and will not obtain approval for any labels with similar claims until the company can demonstrate the ability to ensure their accuracy. BASIS: Previous regulation and policy have not addressed the use of reduced price or money saving claims which are becoming more prevalent throughout the marketplace. However, it is the responsibility of the Department through the prior label system to ensure that all labeling terminology is accurate and not misleading. At the time of label approval the information necessary to assure the validity of such a claim may not be available. Thus the labels will be approved with the understanding that firms are responsible for demonstrating that the foods are being offered to the consumer at reduced prices commensurate with a claim. The goal of this policy is to establish guidelines for the use of these terms while not unnecessarily involving the staff in questions of pricing policy.

To: Branch Chiefs

Policy Memo 004A August 20, 1980

From: Robert G. Hibbert Director MP Standards and Labeling Division Subject: Sweet Red Peppers and Pimientos ISSUE: The labeling of sweet red peppers as pimientos. DECISION: Pimientos are classified as a variety of sweet red peppers however, not all sweet red peppers are pimientos. To use pimiento in a product name, e.g., "Pickle and Pimiento Loaf," pimientos must be the variety of sweet red peppers used. See also Section 17.13(0)(3) of the Meat and Poultry Inspection Manual. RATIONALE: In the past, sweet red peppers have been considered as pimientos. However, according to several references, pimientos are defined only as a variety of sweet red peppers. Therefore, all types of sweet red peppers would not fulfill the definition of pimiento. This policy should assure that products with pimiento in the product name contain pimientos.

To: Branch Chiefs, SLD

Policy Memo 005A November 25, 1987

From: Margaret O'K. Glavin, Director Standards and Labeling Division Technical Services Subject: Labeling of Certain Cooked Sausage Products Containing Both Livestock and Poultry Ingredients ISSUE: What names should be used to identify nonstandardized cooked sausages of the frank, bologna, Vienna, and knockwurst variety which contain both livestock and poultry ingredients? POLICY: This policy memo supersedes Policy Memo 005. It does not apply to cooked sausage products which contain poultry ingredients up to 15 percent of the total ingredients (excluding water). The labeling of these products must be in accordance with 9 CFR 319.180. Meat food products (i.e., those in which more than 50 percent of the livestock and poultry product portion consists of livestock ingredients): Such cooked sausage products which contain poultry ingredients at more than 15 percent of the total ingredients (excluding water) must have product names that indicate the species of livestock and kind(s) of poultry ingredients, e.g., Beef and Turkey Frankfurter or Frankfurter made From Beef and Turkey. Poultry products (i.e., those in which more than 50 percent of the livestock and poultry products portion consists of poultry ingredients): Such cooked sausage products which contain livestock ingredients at more than 20 percent of the total poultry and livestock ingredients must have product names that indicate the kind(s) of poultry and species of livestock ingredients, e.g., Turkey and Beef Frankfurter or Frankfurter Made From Turkey and Beef. Such cooked sausage products which contain livestock ingredients at 20 percent or less of the total poultry and livestock ingredients, must have product names that are appropriately qualified to indicate the inclusion of livestock ingredients, e.g., Turkey Frankfurter - Pork Added or Turkey Frankfurter - With Pork. (The product names of cooked sausage products which contain no livestock ingredients designate the kind(s) of poultry ingredients, e.g., Turkey Frankfurter.) Cooked sausage products containing over 50 percent meat ingredients would carry the red meat legend while those containing over 50 percent poultry ingredients would carry the poultry legend. See Policy Memo 087A regarding word size in the labeling of product names. RATIONALE: Frank, bologna, Vienna, knockwurst, and similar cooked sausages are standardized meat food products subject to 9 CFR 319.180. Those products may contain poultry ingredients up to 15 percent of the total ingredients, excluding water. The poultry (and other) ingredients in such products are declared in the ingredients statements. This policy memo is issued to ensure that other nonstandardized, comminuted, semisolid cooked sausage products which contain both livestock and poultry ingredients are properly identified. The approach to nomenclature set forth herein is essentially the one utilized in Policy Memo 029, Labeling Poultry Products Containing Livestock Ingredients, and Policy Memo 030A, Labeling Meat Food Products Containing Poultry Ingredients. To: Branch Chiefs Policy Memo 006

July 30, 1980 From: Robert Hibbert, Director MPSLD Subject: Poultry Salami Products (Policy Book page 144) ISSUE: Product names that will truthfully and accurately describe the type of salami made from poultry. DECISION: Poultry sausages prepared to resemble salami and offered to consumers as a salami shall bear product names as follows: 1. "(Kind) Salami," e.g., Turkey Salami, shall be the product name when the moisture to protein ratio in the finished product does not exceed 1.9:1. This product resembles a dry salami made from red meats. 2. "Cooked (Kind) Salami," e.g., Cooked Turkey Salami, shall be the product name when the product is cooked and the moisture to protein ratio is above 1.9:1. This product resembles a "Cooked Salami" made from red meats. RATIONALE: Labels have been inadvertently approved bearing the product name "(Kind) Salami," e.g., Turkey Salami for both cooked and dry varieties of poultry salami. This decision reiterates the policy identified in the Policy Book and is consistent with the policy followed for the labeling of red meat salami products. The consistency afforded by the policy provides a descriptive product name that allows the consumer to make an informed value judgment in the market place.

To: Branch Chiefs MPSLD

Policy Memo 010 September 8, 1980

From: Robert G. Hibbert, Director MPSLD Subject: Label Approval Guidelines for Sausages Containing Cheese ISSUE: What are the Guidelines for Sausages Containing Cheese as an Ingredient?

POLICY: Sausages may contain cheese under the following conditions. 1. If there is a standard for that particular sausage it must be met as though it contained no cheese. 2. The cheese must characterize the product and appear as part of the product name. Ex. "Italian Sausage with Cheese," "Salami with Cheese." BASIS: This policy was established for a product identified as "Sweet Italian Sausage with Cheese and Parsley." See Control Sheet 78-158 dated December 20, 1978. It is felt the addition of cheese with proper label declaration is a product in itself and that the sausage identified must meet the standard for that particular sausage without cheese.

To: Branch Chiefs MPSLD

Policy Memo 011 September 8, 1980

From: Robert G. Hibbert, Director Subject: Label Approval Guidelines for Sausages and Pudding Containing Potatoes ISSUE: What are the appropriate guidelines for these products?

POLICY: Labels for sausages and pudding identified as "Potato Sausage," "Potato Brand Sausage," "Potato Ring," and "Potato Brand Sausage" should be approved under the following guidelines: 1. The product must contain a minimum of 45 percent meat and no byproducts. 2. Water must be limited to 3 percent at formulation. 3. When extenders or binders are used, they must be limited to 3.5percent and 2 percent of the finished product. 4. The product must include a minimum of 18 percent potatoes. Sausage identified as "Swedish Style Potato Sausage" is provided for under the following guidelines: 1. The product must contain a minimum of 65 percent meat and no byproducts 2. Water must be limited to 3 percent at formulation. 3. No extenders or binders are permitted. 4. The product must include a minimum of 18 percent potatoes. Meat food product identified as "Potato Pudding" is provided for under the following guidelines: 1. The product must contain a minimum of 18 percent potatoes. 2. The product does not meet the other requirements for products identified as "Potato Sausage," "Potato Ring," or "Swedish Style Potato Sausage." BASIS: The present policies concerning sausages that contain potatoes are confusing and difficult to follow. This delineation of policy will hopefully serve to clarify the matter without departing to any great extent from past practices or approvals.

To: Branch Chiefs MPSLD

Policy Memo 012 September 8, 1980

From: Robert G. Hibbert, Director MPSLD Subject: Uncooked Meat and Poultry Teriyaki ISSUE: Can a meat food product be identified as a Teriyaki product without being cooked? POLICY: We are not requiring that a meat or poultry teriyaki be cooked provided certain labeling requirements are met. The label must be so designed that a prominent statement is on the principal display panel informing the consumer that the product is not cooked. Example" "Ready to Bake," "Ready to Cook" and "Raw." BASIS: Further review of information presented has indicated that meat and/ or poultry marinated in teriyaki sauce would be recognized as teriyaki and that a consumer would cook prior to consumption. It is felt that prominent labeling relating the fact that the product is not cooked must be on the principal display panel.

To: Branch Chiefs MPSLD

Policy Memo 013 September 12, 1980

From: Robert G. Hibbert, Director MPSLD Subject: Chili Verde and Chili Colorado ISSUE: Required ingredients for products labeled "Chili Verde" and "Chili Colorado." POLICY: "Chili Verde" meets the requirements of section 319.300 and the chili peppers used are exclusively green chilis or Verde chili peppers. If a prepared chili powder is used, it must have been prepared from exclusively green chilies or Verde chili peppers. "Chili Verde with Beans" shall comply with section 319.301 and the above requirements for "chili Verde." Chili Colorado meets the requirements of section 319.300 and the chili peppers used are exclusively the red variety. If a prepared chili powder is used it must be prepared from exclusively red chili peppers. "Chili Colorado with Beans" shall comply with section 319.301 and the above requirements for "Chili Colorado." BASIS: Chili peppers are available both as the red and green varieties. It is common to prepare Mexican and Spanish dishes with one or the other exclusively and identify the product as "Verde" (green) or as Colorado or Rojo (Red). The word "Colorado" is used for red more than "Rojo" in Mexico. The term "Rojo" is used more in Spain, Puerto Rico, and Cuba.

To: Branch Chiefs MPSLD

Policy Memo 014 September 12, 1980

From: Robert G. Hibbert, Director MPSLD Subject: Handling Statements in Addition to the Requirements of 9 CFR 317.2(k) and 9 CFR 381.125 ISSUE: Acceptable handling statements in addition to those required in sections 317.2(k) and 381.125 of the Code of Federal Regulations. POLICY: Labels that feature terms such as, "Keep Refrigerated-May Be Frozen" or "Keep Refrigerated-Can Be Frozen" are considered acceptable informative phrases. RATIONALE: After reviewing data of prior label approvals and input from the label reviewers, we found this has been accepted for some time and apparently serves a consumer need for acceptable handling after purchase.

To: Branch Chiefs MPSLD

Policy Memo 015A June 22, 1981

From: Robert G. Hibbert, Director MPSLD Subject: Sausage Product Labeled Linguica - 9 CFR 319.140 ISSUE: Standard for product labeled "Linguica." POLICY: This replaces Policy Memo #15 on Linguica. Sausage product labeled "Linguica" is considered to be a Portuguese-type sausage containing pork to the exclusion of other meat and meat by-products and usually containing condiments such as vinegar, cinnamon, cumin seed, garlic, red pepper, salt and sugar. The product may also contain paprika. Linguica usually contains nonfat dry milk and cures are acceptable in this product. RATIONALE: The present policy combines the standards for Longaniza and Linguica although the two products have different, distinct standards. The standards are being separated to eliminate confusion. The treatment for trichinae will be determined by the Field Operations program.

To: Branch Chiefs

Policy Memo 016B August 18, 1994

From: Cheryl Wade, Director Food Labeling Division, RP Subject: Combinations of Ground Beef or Hamburger and Soy Products ISSUE: The labeling of combinations of ground beef or hamburger and soy products. POLICY: This Policy Memo replaces Policy Memo 016A. Combinations of ground beef or hamburger and soy products may be descriptively labeled, e.g., "Hamburger and Textured Vegetable Protein Product" or "Ground Beef and Isolated Soy Protein Product" if the combination product is not nutritionally inferior to hamburger or ground beef. If the combination products are nutritionally inferior, they are to be labeled as Imitation Ground Beef (or Imitation Hamburger) or Beef Patty or Beef Patty Mix in accordance with Section 317.2(j)(1) and Section 319.15(c) respectively. RATIONALE: The descriptive labeling permitted for combination products not nutritionally inferior to ground beef or hamburger is considered to be a useful and informative alternative to the names beef patty or beef patty mix and is in keeping with the Department's policy to allow descriptive labeling, in lieu of imitation labeling, for products which are not nutritionally inferior to a standardized product. Policy Memo 016B eliminates the section from Policy Memo 016A which encouraged nutrition labeling even though it was not required, since nutrition labeling is now mandatory on most multi-ingredient products.

To: Branch Chiefs MPSLD

Policy Memo 017 December 9, 1980

From: Robert G. Hibbert, Director MPSLD Subject: Potassium Sorbate ISSUE: The use of potassium sorbate as an external mold inhibitor on imitation dry sausage products, dry beef snacks, and beef jerky. POLICY: Potassium sorbate may be used as an external mold inhibitor (applied by dipping or spraying) on imitation dry sausage products, dry beef snacks which may contain soy flour, and beef jerky. The presence of potassium sorbate must be declared on the label. BASIS: The current regulation (9 CFR 318.7(c)(4)) states that potassium sorbate may be used on dry sausage casings to retard mold growth and in oleomargarine or margarine to preserve the product and to retard mold growth. The regulation has also been interpreted to permit the use of potassium sorbate on beef jerky (letter of I. Fried dated July 26, 1978 and Policy Book, p. 106a). Imitation dry sausages and dry beef snacks are not unlike dry sausage and beef jerky in terms of moisture/protein ratio. Therefore, label approvals involving external use of potassium sorbate on imitation dry sausage, dry beef snacks and beef jerky represent a consistent application of the regulation.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 018A December 26, 1985

From: Joseph Germano/Acting for Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Dual Weight Requirements for Stuffed Poultry Labels (9 CFR 381.121 (b)) ISSUE: When must the label on consumer size retail packages of stuffed poultry and other stuffed poultry products declare the total net weight of the product and the minimum weight of the poultry in the product? POLICY: This replaces Policy Memo 018. Poultry products that consist solely of bone-in poultry and stuffing such as a "Stuffed Turkey" and Stuffed Turkey Breast" shall bear weight statements on its label indicating the total net weight of the product and a statement indicating the minimum weight of the poultry in the product. A poultry product such as a dinner or an entree that contains a stuffed poultry product as one of its components needs only the total net weight of the product on the label. RATIONALE: The amount of stuffing in a whole bone-in bird or part is dependent upon the size of the bird, the bird's cavity, and the extent to which the product is stuffed. Because the amount of stuffing is difficult to determine, the consumer needs to be informed about the amount of poultry in the product compared to the amount of stuffing. This policy is not applicable to stuffed boneless poultry where the amount of stuffing is not dependant upon cavity size and where the amount of stuffing is more easily determined by examination. Moreover, the stuffing content of these products is generally self-limiting in that the boneless poultry encasement tends to disassemble when overstuffed. Dinner and entree products are also exempt because of the minimum poultry requirements they must meet. For example, the poultry products inspection regulations require a poultry dinner to contain 18 percent or 2 ounces of cooked deboned poultry meat irrespective of the amount of stuffing. The same is true of an entree for which minimum poultry content is based on the total of all components.

To: Branch Chiefs

Policy Memo 019B August 18, 1994

From: Cheryl Wade, Director Food Labeling Division, RP Subject: Negative Ingredient Labeling ISSUE: Appropriate labeling of meat and poultry products bearing negative ingredient statements. POLICY: This policy memo replaces Policy Memo 019A. The guidelines for the use of negative ingredient statements on meat and poultry labels are as follows: 1) Negative labeling is allowed if it is unclear from the product name that the ingredient is not present. For example, the use of the term "no beef" on the label of "Turkey Pastrami" would further clarify that the product does not contain beef. 2) Negative labeling is allowed if the statement is beneficial for health, religious preference, or other similar reasons. For example, highlighting the absence of salt in a product would be helpful to those persons on sodium-restricted diets. 3) Negative labeling is allowed if the claims are directly linked to the product packaging, as opposed to the product itself. For example, flexible retortable pouches could bear the statement "No Preservatives, Refrigeration or Freezing Needed with This New Packaging Method." 4) Negative labeling is allowed if such claims call attention to the absence of ingredients because they are prohibited in a product by regulation or policy. The statement must clearly and prominently indicate this fact, so as not to mislead or create false impressions. For example, "USDA regulations prohibit the use of preservatives in this product" would be an acceptable statement for ground beef. 5) Negative labeling is allowed to indicate the absence of an ingredient when that ingredient is expected or permitted by regulation or policy. This could also apply to ingredients which are not expected or permitted by regulation or policy if the ingredients could find their way into the product through a component. For example, the use of "no preservatives" on the label of "spaghetti with meat and sauce" (where regulations do not permit the direct addition of preservatives) would be acceptable if the product contained an ingredient, such as cooking oil, which could contain antioxidants but do not. The guidelines contained in this policy memo do not preempt the requirements of the nutrition labeling regulations. Therefore, negative claims such as "unsalted" would have to comply with the provisions stated in the nutrition labeling regulations. RATIONALE: These guidelines are issued to identify the policy for labeling negative ingredient claims since the promulgation of the nutrition labeling regulations. Essentially, the guidelines reflect the policy that has been applied for a number of years, with the exception of nutritive ingredients and health-related claims that will be subject to the provisions stated in the nutrition labeling regulations.

It is believed that negative ingredient labeling, when properly used, can be useful and meaningful to consumers as an aid in understanding product contents. It also offers a direct means of alerting consumers to the absence of ingredients they prefer to avoid for religious beliefs, food intolerance or other nonnutrition related reasons. Using the above guidelines, consumers can be protected from claims believed to be misleading without precluding the use of accurate, informative statements on product labels. Where the direct addition of ingredients, such as artificial colors, preservatives, etc., are prohibited by regulation, previous policy required an accompanying explanation to the negative claim, such as "USDA does not permit the use of artificial colors in this product." Realizing that, in some cases, preservatives and other food additives could be introduced into the food indirectly through a component, it is not necessary to accompany certain negative claims with a qualifier when the product includes a component that could contain food additives but do not.

To: Branch Chiefs MPSLD

Policy Memo 020A March 26, 1981

From: Robert G. Hibbert, Director MPSLD Subject: Labeling of Cooked Mettwurst ISSUE: Whether sausage products currently labeled as "Mettwurst" may be precooked and how they should be labeled. POLICY: Mettwurst is a cured sausage. Mettwurst which is cooked must be labeled "cooked mettwurst," and may contain up to 10 percent water based on the finished product. RATIONALE: The Policy Book (p. 88) currently states that mettwurst is an uncooked sausage. This presumably reflects traditional practice in which the time interval between production and consumption was shorter than it is today. With the development of larger distribution networks and extended shelf exposure, producers have resorted to cooking mettwurst before it is sold. This is supported by the label approval record which shows that a significant number of products currently labeled as "mettwurst" are pre-cooked. Implementation of this policy will resolve the discrepancy between the Policy Book and the label approval record regarding cooked mettwurst. The water limitation for cooked mettwurst is consistent with that for cooked bratwurst.

To: Branch Chiefs MPSLD

Policy Memo 021 FEB 6 1881

From: Robert G. Hibbert, Director MPSLD Subject: Sausage Products Labeled "Longaniza" and "Longaniza Puerto Rican Style" ISSUES: Standard for product labeled "Longaniza" and "Longaniza Puerto Rican Style" POLICY: "Longaniza" is an acceptable name for Puerto Rican sausage made from pork which may contain beef but does not contain annatto. "Longaniza Puerto Rican Style" is acceptable labeling for sausage made from pork which may contain beef and does contain annatto. Added fat is not permitted in either product, although up to three percent lard may be used as a carrier for annatto in "Longaniza Puerto Rican Style." When annatto is used in "Longaniza Puerto Rican Style" it should be included in the ingredients statement as "annatto" and declared on the label by a phrase such as "colored with annatto" in accordance with section 317.2(j)(5) of the meat inspection regulations. RATIONALE: After discussing the nature of these products and the traditional manufacturing technique used for these products with inspection personnel located in Puerto Rico, it is apparent that a policy change is necessary to more accurately identify and differentiate the content and labeling of these two products. The use of annatto as a distinguishing feature between these two kinds of sausage is supported by a statistical analysis of past label approvals. The treatment for trichinae will be determined by the Field Operations Program.

To: Branch Chiefs

Policy Memo 023 FEB 10 1981

From: Robert G. Hibbert, Director MPSLD Subject: Labeling of Boneless Ham Products (9 CFR 317.2(b)(13)) ISSUE: Under what circumstances is the use of the term "ham" without qualification an acceptable product name and under what circumstances must the product name be so qualified. POLICY: The term "sectioned and formed" is no longer required on boneless ham labels. Product previously labeled "ham - sectioned and formed" may now be simply labeled as "ham". The same labeling policy applies to product to which is added small amounts of ground meat as a binder; provided such ground meat is made from trimmings (such as shank meat) that are removed during the sectioning process. The addition of ground meat must be limited to natural proportions and shall not result in any readily discernible appearance of a ground or emulsified product. Ham having any discernible appearance of a ground or emulsified product shall be labeled "a portion of ground ham added." This does not change any labeling policy or conformance with existing product standards. Policies regarding the required use of terminology such as "chunk," chunked and formed" and "ground and formed" will continue unchanged. RATIONALE: Although terminology such as "sectioned and formed" has been required for several years, concerns have developed regarding the appropriateness of its use. Rapid advances in meat processing have provided the technology to prepare ham products, with and without ground meat added, that assume all the characteristics associated with the term "ham. Since those products conform to the public's expectations for ham, consumers may be confused or misled by this terminology which seems to connote an inferior product. Moreover, the original requirement has not been uniformly applied at the inspection level. Therefore, discrepancies and confusion exist in areas such as contract bidding. Certain types of processing, such as grinding, serve to recharacterize the product in a way that is significantly different from that normally expected by consumers. Therefore, qualifiers such as "chunked and formed" and aground and formed" will continue to be required.

To: Branch Chiefs

Policy Memo 027 June 15, 1981

From: Robert G. Hibbert, Director MPSLD Subject: Clarification of "Meat" Definition in Chopped Beef, Ground Beef or Hamburger ISSUE: What ingredients, defined as meat in the regulations (301.2 (tt)), may be utilized in preparing chopped beef, ground beef or hamburger (319.15(a) and (b))? POLICY: Beef of skeletal origin, or from the diaphragm or esophagus (weasand) may be used in the preparation of chopped beef, ground beef or hamburger. Heart meat and tongue meat, as organ meats, are not acceptable ingredients in chopped beef, ground beef or hamburger. RATIONALE: Historically organ meats such as heart meat and tongue meat have not been permitted as ingredients in chopped beef, ground beef or hamburger. Heart meat and tongue meat have never been considered as beef or permitted to be declared as beef on labels and are not expected ingredients in chopped beef, ground beef or hamburger.

To: Branch Chiefs

Policy Memo 029 SEP 4 1981

From: Robert G. Hibbert, Director SLD Subject: Labeling Poultry Products Containing Livestock Ingredients ISSUE: How poultry products containing livestock ingredients should be labeled. POLICY: Poultry products containing livestock ingredients in amounts that exceed 20 percent of the total livestock and poultry product portion of the poultry product must be descriptively labeled to indicate the presence of the livestock ingredients, e.g., Chicken and Beef Stew or Stew made with Chicken and Beef. Poultry products containing livestock ingredients in amounts at 20 percent or less of the total livestock and poultry product portion of the poultry product must have names that are qualified to indicate the presence of the livestock ingredients, e.g., Chicken Stew-Beef Added. However, poultry products that do not meet specified minimum poultry ingredient requirements because livestock ingredients are replacing any part of the required poultry ingredients must be descriptively labeled to indicate the presence of livestock ingredients, e.g., Turkey and Pork Chop Suey. RATIONALE: Consumers do not expect livestock ingredients in products identified as poultry products. Therefore, to ensure that product names of poultry products are not misleading to consumers, the presence of the livestock ingredients should be indicated. In the case of poultry products containing significant quantities of livestock ingredients it is important that the livestock ingredients become a part of the basic product name. Similarly, it is important that poultry products not meeting specified minimum poultry ingredient requirements have descriptive names that include the presence of the livestock ingredients. The use of a qualifier to the product name satisfactorily indicates the presence of the livestock ingredients for poultry products containing proportionately smaller amounts of livestock ingredients. The 20 percent level has been used for other products and is considered a satisfactory benchmark.

To: Branch Chiefs, SLD

Policy Memo 030A SEP 13 1982

From: Robert G. Hibbert, Director Standards and Labeling Division, MPITS Subject: Labeling Meat Food Products Containing Poultry Ingredients ISSUE: How meat food products containing poultry ingredients should be labeled. POLICY: This Policy Memo replaces and clarifies Policy Memo 030. Meat food products containing poultry ingredients in amounts that exceed 20 percent of the total livestock and poultry product portion of the meat food product must have product names that indicate the presence of the poultry ingredients, e.g., Beef and Chicken Chili or Chili made with Beef and Chicken. Meat food products containing poultry ingredients in amounts at 20 percent or less of the total livestock and poultry product portion of the meat food product must have product names that are qualified to indicate the presence of the poultry ingredients, e.g., Beef Stew - Turkey Added. However, meat food products that do not meet specified minimum livestock ingredients requirements because poultry ingredients are replacing any part of the required livestock ingredients must have product names that indicate the presence of the poultry ingredients, e.g., Beef and Turkey Stew or Stew made with Beef and Turkey. This policy does not apply to: (1) red meat products that are expected to contain poultry ingredients, e.g., Brunswick Stew and Potted Meat Food Product (Section 319.761); (2) cooked sausages identified in section 319.180 of the meat regulations (see Policy Memo 005); or (3) non-specific loaves, rolls, logs, etc., e.g., Pickle and Pimento Loaf. RATIONALE: Consumers do not expect poultry ingredients in products historically prepared from red meats only. Therefore, to ensure that product names of meat food products are not misleading to consumers, the presence of the poultry ingredients should be indicated. In the case of meat food products containing significant quantities of poultry ingredients, it is important that the poultry ingredients become a part of the basic product name. Similarly, it is important that meat food products not meeting specified minimum livestock ingredient requirements have product names that include the presence of poultry ingredients. The use of a qualifier to the product name satisfactorily indicates the presence of the poultry ingredients for red meat products containing proportionately smaller amounts of poultry ingredients. The 20 percent level has been used for other products and is considered a satisfactory benchmark. Non-specific loaves, logs, rolls, etc., are not covered by this policy since these products are expected to contain various meat components and extenders and because the ingredients statement of these products, in accordance with the regulations, constitutes a part of the product name. Potted Meat Food Product is not covered by his policy because chicken has been used in its preparation for a number of years and has become an expected ingredient.

To: Branch Chiefs, SLD

Policy Memo 031A July 23, 1986

From: Margaret O' K. Glavin , Director Standards and Labeling Division, MPTIS Subject: Salami Labeling ISSUE: What is the appropriate labeling for the product Salami? POLICY: The product "Salami" must be labeled to include the word "Cooked" regardless of the type and size of its packaging, unless it is one of the following:
1) A salami with a moisture protein ratio of no more than 1.9 to 1;
2) "Genoa salami" with a moisture protein ratio of no more than 2.3:1;
3) "Sicilian salami,' with a moisture protein ratio of no more than 2.3 : 1 ; or
4) Labeled, as . . . , (a) Kosher Salami, (b) Kosher Beef Salami , (c) Beef Salami, (d) Beer Salami, and
(e) Salami for Beer. RATIONALE: At one time, "Cooked Salami" in consumer size packages was not required to be labeled Cooked Salami, since it was believed that the differences in the nature of this product, in comparison to dry salami products, were obvious from the packaging. We indicated in policy memo 031 that we believed such a position was untenable and created a situation that was not easily controlled. Cooked Salami and the dry variety have vastly different characteristics including keeping qualities. Thus, it is necessary to use descriptive labeling for this product that will serve to alert consumers to the type of product being marketed, regardless of the type and size of packaging used. However, there are certain salamis, as indicated by the above historically established names, which are not regarded as dry salamis and which have traditionally not been labeled to include the term cooked". These were not spelled out in Policy Memo 031. Therefore, we are revising the memo as 031A to include them.

To: Branch Chiefs

Policy Memo 032 SEP 4 1981

From: Robert G. Hibbert, Director Standards and Labeling Division, MPITS Subject: Raw Poultry Meat (381-117(b)) ISSUE: Appropriate labeling requirements for poultry meat obtained from other than young poultry. POLICY: The nomenclature for poultry meat obtained from other than young poultry shall include the class designation such as "Yearling Turkey Meat" or "Mature Chicken Meat". BASIS: Section 381.117(b) specifies that parts or portions cut from mature poultry shall include along with the part or portion name, the class name or the qualifying term "mature unless the product is cooked or heat processed. Questions have arisen as to the applicability of this provision to the labeling of poultry meat which is not cooked, heat processed or otherwise recharacterized by further processing. The term portions appears to be applicable to this category of product, and a contrary interpretation seems inconsistent with the intent of the regulation. There appears to be an increasing amount of mature poultry meat being diverted to retail concerns, and the need to allow consumers to distinguish between the various types of product is as valid with a portion of meat as it is with a part.

To: Branch Chiefs, SLD

Policy Memo 033 SEP 4 1981

From: Robert G. Hibbert, Director Standards and Labeling Division Subject: Labeling of Cured Meat Products ISSUE: Can the traditional names of cured meat products be used even though mechanical reduction has taken place before the product has acquired the characteristics expected? POLICY: The traditional names of cured meat products, e.g., bacon, may be used even though mechanical reduction, e.g., chopping or chunking, has taken place before the product has acquired the characteristics expected of the product provided the finished product acquires the characteristics expected. Furthermore, the mechanical reduction must be noted in the product name or in a qualifier to the product name (e.g., chopped bacon or bacon-chopped and formed). RATIONALE: In the past, the traditional names of cured meat products could only be used if the products were made in the traditional manner prior to chopping, chunking, etc. and any subsequent reforming. For example, a product labeled chopped and formed bacon" would be the name for a product that consisted of bacon prepared by curing and smoking pork bellies in the usual manner and then chopping and forming the product. If, for example, chopped pork bellies were cured and smoked, or cured pork bellies were chopped prior to smoking and any reforming, the product name could not include the term "bacon" but, instead consisted of a description of the steps taken to prepare the raw product, e.g., cured, chopped, smoked, and formed pork belly. After careful review, this policy is viewed as unnecessarily restrictive. As long as the finished product has all the characteristics and ingredients of the traditional product, conforms to consumer expectation, and is properly labeled there is no need to dictate the order of processing. Therefore, this new policy is established to provide flexibility to processors without sacrificing the quality of the product reaching consumers.

To: Branch Chiefs SLD

Policy Memo 034 OCT 1 1981

From: Robert G. Hibbert, Director SLD Subject: Fresh Chorizos ISSUE: Limitations on water and other liquids in fresh chorizos. POLICY: Fresh chorizos (uncured, uncooked) shall not contain more than three percent added water in accordance with section 319.140. These products may contain vinegar under section 318.7(c)(1). The vinegar used must have a strength of no less than 4 grams of acetic acid per 100 cubic centimeters (20oC). RATIONALE: "Chorizo" is Spanish for "pork sausage."* Its meaning has expanded in commercial practice to include dry or semi-dry cured pork sausage as well as uncooked sausages that may contain beef. The standards regulations for uncooked sausage are quite specific in limiting added water or ice to three percent. The fresh sausage standards do not, however, restrict the content of liquids other than water, except for condimental proportions of condimental substances which may be liquid. The policy specifies a minimum strength for vinegar added to chorizos in order to control dilution with additional water. The minimum strength specified above is consistent with the trade and regulatory issuances of the Food and Drug Administration. References: * Cassell's Spanish Dictionary, E.A. Peers et al. (eds.), Funk and Wagnalls, New York, 1968. * Spanish and English Dictionary, Velazquez et al. (eds.), Follett Publishing Company, Chicago, 1967.

To: Branch Chiefs SLD

Policy Memo 035 Oct 27 1981

From: Robert G. Hibbert, Director SLD Subject:High Fructose Corn Syrup (HFCS) in Meat or Poultry Products
ISSUE: Appropriate use limitations and labeling of HFCS in meat or poultry products.
POLICY: HFCS may be used to flavor meat or poultry products in amounts sufficient for its intended purpose
provided the following conditions are met:
1. HFCS must contain not less than 40 percent fructose on a solids basis. 2. HFCS must have a dextrose equivalence (D.E.) of not less than 93. 3. HFCS must have a sweetening power greater than or equal to sugar (sucrose). 4. HFCS must be identified on the label as High Fructose Corn Syrup in the ingredient statement, curing statement, etc. RATIONALE: The meat inspection regulations (9 CFR 318.7(c)) provide for the use of corn syrup as a flavoring for certain meat products but limits usage to 2 percent calculated on a dry basis. These restricted uses of corn syrup have been in effect for many years. These usage limits were established to prevent use of corn syrup as a "filler" or economic diluent. In recent years the corn industry has developed a new class of sweeteners known as HFCS which were not commercial products of use when these regulations were promulgated. The dextrose equivalence and fructose specifications given above are consistent with industry specification sheets for these products. HFCS, as defined by items 1 through 3 above, is self limiting in its usage level, as is sugar, and cannot serve as an essentially inert filler or economic diluent. Since HFCS was not an item of commerce when the regulatory restrictions were promulgated, HFCS was not intended to be included in the corn syrup category and should not be restricted in usage as are traditional corn syrups. The maximum amount of corn syrups currently allowed in poultry products (9 CFR 381.147(f)) is that amount that is "sufficient for purpose." This policy on HFCS does not change that limitation. However, this policy does require that HFCS used in poultry products be declared on the label as "High Fructose Corn Syrup." This provision is necessary to enable individuals with fructose intolerance to avoid foods containing fructose.

To: Branch Chiefs SLD

Policy Memo 036 Nov 6 1981

From: Robert G. Hibbert, Director SLD Subject: Plastic Cans ISSUE: Whether plastic packaging for meat food products may be considered to be a "can" under 319.104(e). POLICY: Plastic material may be used to package cured pork products under section 319.104(e) of the meat inspection regulations only if it meets the following requirements: (1) The plastic packaging material is approved by the Food and Drug Administration (FDA) and/or the USDA Food Ingredient Assessment Division as appropriate. (2) The plastic container encloses the product during thermal processing. (3) The plastic container is impermeable and hermetically sealed. (4) The plastic container has a label bearing all required handling statements. RATIONALE: In response to an industry request for approval of flexible crimped nylon tubing as a "can" under section 319.104(e), the USDA consulted several can manufacturers and trade associations. The consensus was that a can should be retortable and hermetically sealed. The Dictionary of Standard Definitions of the American Society for Testing and Materials (ASTM) states that a can may also be made of plastic. In the interest of public safety, any plastic material used in packaging cured pork products must be approved by the Food and Drug Administration and/or the Food Ingredient Assessment Division as a food packaging material.

To: Branch Chiefs, SLD

Policy Memo 037 Nov 4 1981

From: Robert G. Hibbert, Director Standards and Labeling Division Subject: Alternate Principal Display Panels (9CFR 317.2(d) and 381.116(b)) ISSUE: When is a panel bearing a number of mandatory labeling features considered an alternate principal display panel? POLICY: The determination as to whether or not a panel is an alternate principal display panel shall be based on whether or not the panel is likely to be displayed, presented, shown, or examined under customary conditions of sale. In some cases this means that the manufacturer will need to provide us with information regarding the manner in which the product is marketed and displayed. If the intent of the panel cannot be determined or demonstrated, and it has the appearance of a principal display panel, the presence of three or more mandatory labeling features shall serve to characterize the panel as an alternate principal panel. As such, any remaining mandatory features required to be placed on a principal display panel must also be included. RATIONALE: In the past, the determination as to whether or not a panel is an alternate principal display panel has been based solely on the fact that a manufacturer has elected to display a certain number of mandatory labeling features on the panel. After careful review of this policy, it has been decided that this approach may not always be the best method for making this determination since there are occasions when a panel bearing several mandatory labeling features would not serve as an alternate principal display panel, i.e., a panel likely to be presented under customary conditions of sale. Therefore, this determination will be made by reviewing the label and any information presented by the manufacturer to help us determine the purpose of the panel. If, however, the purpose of the panel cannot be demonstrated or determined, it is believed that the presence of three or more mandatory features sufficiently characterizes the panel as significant enough to require that any remaining mandatory features required on a principal display also be included on the panel.

To: Branch Chiefs, Standards and Labeling Division

Policy Memo 038 Dec 16 1981

From: Robert G. Hibbert, Director Standards and Labeling Division Subject:Labeling Cured Product as "Honey Cured", "Sugar Cured", or "Honey and Sugar Cured" (Sugar and Honey Cured) ISSUE: What are the guidelines for the use of "Honey Cured", "Sugar Cured" or "Honey and Sugar Cured" (Sugar and Honey Cured) on labeling? POLICY: "Honey Cured" may be shown on the labeling of a cured product if: (1) the honey used contains at least 80 percent solids or is U.S. Grade C or above; (2) honey is the only sweetening ingredient or when other sweetening ingredients are used in combination with honey, they do not exceed one-half the amount of honey used; and (3) honey is used in an amount sufficient to flavor and/or affect the appearance of the finished product. "Sugar Cured" may be used on the labeling of a cured product if: (1) the sugar used is cane sugar or beet sugar; (2) sugar is the only sweetening ingredient or when other sweetening ingredients are used in combination with sugar, they do not exceed one-half the amount of sugar used; and (3) sugar is used in an amount sufficient to flavor and/or affect the appearance of the finished product. "Honey and Sugar Cured" or "Sugar and Honey Cured" may also be used on labeling if: (1) the honey and sugar are of the nature described above; (2) the honey and sugar are the only sweetening agents or when other sweetening ingredients are used in combination with the honey and sugar they do not individually exceed either the amount of honey or sugar used and collectively do not exceed one-half the total amount of honey and sugar; and (3) the honey and sugar is used in amounts sufficient to flavor and/or affect the appearance of the finished product. RATIONALE: A labeling claim that purports the product to possess a specific flavor and/or appearance characteristic may be misleading because: (1) the specific flavor is not used; (2) the specific flavor is used in an amount insufficient to characterize the product; and (3) a substitute ingredient is used that resembles or reinforces the flavor and/or appearance characteristics expected. The flavor and/or appearance characteristics imparted to a product by honey and sugar are similar, both impart sweetness and when heated have a tendency to darken. However, there are other sweetening ingredients such as dextrose, corn syrup, and sorbitol that can impart similar characteristics. These ingredients could substitute, in whole or in part, for the honey and/or sugar necessary to characterize a product. Such substitution in a product bearing a honey and/or sugar claim would mislead the consumer into believing that the flavor characteristics and/or appearance of the product were due to the use of the specific flavor claimed. Therefore, this policy establishes guidelines for the use of sweetening ingredients in cured products bearing a honey and/or sugar claim on its label. The policy is adopted from the guidelines that have been used for years with regard to "sugar cured" claims.

To: Branch Chiefs, SLD

Policy Memo 040 January 18, 1982

From: Robert G. Hibbert Director SLD Subject: Smoked Products ISSUE: Can products be labeled as "smoked" if they have been exposed to natural liquid smoke which has been transformed into a vapor by mechanical means? POLICY: Products which have been exposed to natural liquid smoke which has been transformed into a vapor (mist, fog, gas) by mechanical means, e.g., atomization may be labeled as "smoked". RATIONALE: Presently, products labeled "Smoked" must be processed with smoke generated from burning hardwood, hardwood sawdust, or corn cobs or from natural liquid smoke that has been transformed into a gaseous state by the application of direct heat. The transformation of liquid smoke into a vapor by mechanical means results in products that, after analysis of processing procedures and product sampling, possess the same smoke characteristics as the products resulting from the gaseous natural liquid smoke process which is currently approved. Consequently, products are believed to meet consumer expectations of smoked products. The efficacy of natural liquid smoke for use in producing acceptable smoked meat and poultry products has already been demonstrated.

To: Branch Chiefs, SLD

Policy Memo 041B February 15, 1991

From: Ashland L. Clemons Director Standards and Labeling Division, RP Subject: Labeling of Boneless Ham Products, Whole Muscle Roast Beef Products, and Boneless Poultry Products (Except Turkey Ham (9 CFR 381.171)) Containing Ground and/or Emulsified Trimmings ISSUE: Under what circumstances are the product names for boneless ham products, whole muscle beef products for roasting, and boneless poultry products acceptable without qualification, and when must the product names be qualified to reflect the use of like ground and emulsified trimmings? POLICY: This policy memo replaces Policy Memo 041A (Labeling of Boneless Ham Products) and also addresses boneless roast beef and boneless poultry products. The addition of small amounts of ground or emulsified ham trimmings, beef trimmings, or poultry trimmings to these products may be used without declaration. However, if poultry skin is being used to produce poultry trimmings, it may not exceed natural proportions as prescribed in 9 CFR 381.117 and 381.118 of the Poultry Products Inspection Regulations. The amount of ground or emulsified trimmings that may be used can represent no more than 15 percent of the fresh or green weight of the ham, beef, or poultry block at the time of formulation (e.g., 85 lbs. intact muscle and 15 lbs. of trimmings). these trimmings may be from a different process, however, they must be derived from like cuts or parts, e.g., emulsified round trimmings injected into product called "Boneless Roast Beef Round," emulsified breast meat trimmings injected into product called "Boneless Roasted Turkey Breast," or emulsified chuck trimmings injected into product called "Cooked Roast Beef" derived from the beef chuck. The information pertaining to the source of trimmings and cut of product being used must be indicated in the product formulation on label submittals. Emulsified trimmings consist of suspending ground trimmings in a curing solution or other solutions (i.e., that impart flavor) through the use of a mechanical emulsifier, then injecting the liquid suspension directly into the whole muscle portion of the hams, beef roasts, or poultry products. The emulsified suspension must be used during the same day of production. Furthermore, a written proposal outlining processing procedures for injecting the suspensions of ham, beef, or poultry trimmings into the boneless product must be submitted by establishments, through appropriate inspection channels, to the Processed Products Inspection Division, Science and Technology, for review and approval. Such approval is a prerequisite for label use. Products containing more than 15 percent ground trimmings or emulsified trimmings must be labeled to indicate the presence of the ground ham, beef or poultry trimmings added or emulsified ham, beef or poultry trimmings being injected, e.g., "A Portion of Ground Ham Added," "Emulsified Beef Added," "Ground Poultry Trimmings Added," or "Emulsified Beef Trimmings Added." Policies regarding the required use of terminology such as "chunked and formed" and "ground and formed" will continue. RATIONALE: This revision extends coverage of Policy Memo 041A Labeling of Boneless Ham Products (9 CFR 317.2(b)(13)), to ground beef trimmings and ground poultry trimmings, and also reflects changes in technology that enable emulsified trimmings to be added to whole muscle meat and poultry products. Furthermore, these recent advances in processing have provided the technology to process ground trimmings in a curing solution, or other solution, through the use of an emulsifier, then injecting the mixture directly into

the whole muscle portion of the ham, beef roast, or poultry product. It is our belief that products to which ground or emulsified trimmings are added or injected are not recharacterized by levels of trimmings up to 15 percent. A number of establishments have requested approval to inject suspensions of ground trimmings and curing solutions (or other solution) into boneless meat and poultry products.

To: Branch Chiefs, SLD

Policy Memo 042 February 3, 1982

From: Robert G. Hibbert Director SLD Subject: Raw Bone-In Poultry Products Containing Solutions ISSUE: Labeling of raw bone-in poultry and poultry parts to which solutions are added. POLICY: Unless addressed by other regulations and policies, water and/or oil based solutions may be added to raw bone-in poultry and poultry parts at various levels with an appropriate qualifying statement to the product name. The statement must include terms adequate to inform the consumer of the amount and manner of the addition and include the common or usual names of the ingredients in their proper order of predominance (e.g., "Injected with up to 12 percent of a solution of water, salt, and phosphates"). Other similar designations will be considered on their merits. The statement must be contiguous to the product name and printed in a style and color as prominent as the product name. The statement of the manner and amount of addition must be one-fourth the size of the most prominent letter in the product name. The ingredients of the solution can be in print one-eighth the size of the most prominent letter of the product name. Terms such as "Basted," "Marinated", "For Flavoring" and similar terms contemplated within the provisions of Section 381.169 of the poultry products inspection regulation can not be used if the amount of the solution added is more than needed to baste, marinate, or flavor the product. In the case of bone-in poultry and poultry parts, the amount is approximately 3 percent as prescribed by the regulations. RATIONALE: The addition of various water and/or oil base solutions has been approved in various products including beef for further cooking, roasts, bone-in poultry, poultry rolls, and steaks. These solutions are added by injection, marination, etc., to impart favorable flavoring and other sensory characteristics to the finished product. Existing policies and regulations, however, do not address the addition of solutions above the 3 percent level in bone-in products. Such additions are considered appropriate, but since the nature of the product is changed, it is necessary that the product name be qualified to identify the composition of the solution and the manner and the amount of the solution added. This is consistent with policies relating to the addition of solutions to other meat and poultry products. The prohibition of the use of terms such as "Basted", "Marinated" and "For Flavoring" is based on the fact that the level prescribed in the regulation for bone-in poultry products is adequate for basting, marinating, and flavoring. The use of solutions above this stated amount is unnecessary for these purposes.

To: Branch Chiefs, SLD

Policy Memo 044A September 2, 1986

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Raw Boneless Poultry Containing Solutions ISSUE: Labeling of raw boneless poultry and poultry parts to which solutions are added. POLICY: This policy memo replaces Policy Memo 044. Unless addressed by other regulations and policies, water and/or oil based solutions may be added to raw boneless poultry and poultry parts at any level if the addition and the amount of solution are identified. A statement indicating that the addition of a solution has taken place must appear contiguous to the product name wherever it appears on the labeling. "Contains a 6 percent solution" and "Injected with up to 12 percent of a solution" are examples of acceptable statements. The ingredients of the solution may accompany the statement or appear in locations prescribed for ingredients statements. The statement must be one-fourth the size of the most prominent letter in the product name. If the ingredients are included within the statement, they must appear in print one-eighth the size of the most prominent letter of the product name. Terms such as "Basted," "Marinated," "For Flavoring," and similar terms contemplated within the provisions of section 381.169 of the poultry products inspection regulation cannot be used if the amount of the solution added is more than needed to baste, marinate, or flavor the product. In the absence of evidence to the contrary, the amount is believed to be 8.0 percent for boneless poultry. A quality control program must also be approved by the Processed Products Inspection Division before the label can be used. RATIONALE: This policy memo is being issued to clarify the nature of the statement that must accompany the product name whenever solutions are added to raw boneless poultry and poultry parts. Also the permission to place the ingredients of the added solutions in locations normally reserved for ingredients statements is being addressed to provide consistency with present policy which permits the list of ingredients to appear on an information panel (see Policy Memo 007) or in the case of products in cartons on the front riser. The regulations relating to the addition of solutions to ready-to-cook bone-in poultry, which require the solution statement including the list of ingredients to appear on the principal display panel, are still in effect. The addition of various water and/or oil base solutions has been approved in various products including beef for further cooking, roasts, bone-in poultry, poultry rolls, and steaks. These solutions are added by injection, marination, etc., to impart favorable flavoring and other sensory characteristics to the finished product. Existing policies and regulations, however, do not address the addition of solutions to most boneless products. Such additions are considered appropriate, but since the nature of the product is changed, it is necessary that the product be labeled to identify the amount and composition of the solution and its function. Furthermore, both the meat and poultry regulations require that a product have a standardized name or, if none exists, a common or usual name. If neither exists, the product must have a truthful descriptive name. Since these products have neither a standardized or common or usual name, a descriptive name is needed. The traditional name, supplemented with the required qualifiers to create the necessary distinction from the traditional product, serves this function. The prohibition of the use of terms such as "Basted," "Marinated," and "For Flavoring" on the labeling of products containing solutions above the level necessary to baste, marinate, or

flavor the product is consistent with the policies for the addition of solutions to bone-in poultry and poultry parts. The 8 percent level for boneless products is the amount of solution that would be present in the flesh of the poultry, primarily the breast and thighs, after a 3 percent solution was added to the bone-in product in accordance with 9 CFR 381.169. The need for a quality control program is consistent with the requirements of 9 CFR 381.169 for bone-in poultry.

To: Branch Chiefs, SLD

Policy Memo 045 April 7, 1982

From: Robert G. Hibbert Director SLD Subject: Product Names of Margarine Substitutes ISSUE: What guidelines should be followed when approving labels for products that are substitutes for margarine? POLICY: Meat food products that are substitutes for margarine because they contain less than 80 percent fat and/or oil need not be labeled "Imitation" if the product has a fully descriptive name and the finished product contains 15,000 international units of vitamin A per pound. The descriptive name of the product may include the term "Spread" (or "Spred"), which has been widely adopted as a generic fanciful name for this class of products. The following guidelines shall be used in selecting the appropriate descriptive product name: 1. "Animal Fat Spread (or Spred)" is an acceptable product name for a product prepared from animal fat as the sole source of fat. 2. "Animal Fat and Vegetable Oil Spread (or Spred)" is an acceptable product name for a product prepared with a combination of animal fat(s) and vegetable oil(s) in which the vegetable oil(s) content is greater than 20 percent of the total of the fat(s) and oil(s) used but less than 50 percent of the total. 3. "Animal Fat Spread (or Spred)-Vegetable Oil Added" is an acceptable product name for a product prepared with a combination of animal fat(s) and vegetable oil(s) in which the vegetable oil(s) content is 20 percent or less of the total of the fat(s) and oil(s) used but greater than 2 percent of the total. 4. The fanciful name "Spread" (or "Spred") accompanied by a list of all ingredients individually identified by their common or usual name in order of decreasing predominance is an acceptable product name regardless of the nature and amount of fat(s) and/or oil(s) used. In 1, 2, and 3 above the descriptive product name may include the percent of each fat and/or oil and may include the common or usual name of each fat and/or oil used. RATIONALE: Section 301.2(ii)(3) of the meat inspection regulations provides that a product must be labeled "imitation" if it is an imitation of another food. The policy of the agency also permits a descriptive name for the substitute food if the product is not nutritionally inferior to the product being substituted. In the case of margarine-like products, nutritional inferiority is determined on the basis of the product's vitamin A content. Since margarine is required to contain 15,000 international units of vitamin A per pound, margarine-like products must also contain this amount or be considered nutritionally inferior. The word "Spread" (or "Spred") has been adopted by the industry as a term that differentiates these products from margarine and is considered an acceptable term if the fat and/or oil used

in preparing the product is identified generally or specifically in the product name description. The descriptive name including the fat and/or oil is necessary to inform the consumer of the nature of the product. This policy is also consistent with section 317.2(e) with regard to the use of a fanciful name accompanied by a list of ingredients as an alternative to a descriptive product name and with past labeling policy with regard to the use of qualifying statements. The 20 percent level has been used for other products and is considered a satisfactory benchmark.

To: Branch Chiefs, SLD

Policy Memo 047 May 3, 1982

From: Robert G. Hibbert Director SLD Subject: Net Weight Statements on Packages with Header Labels* (9 CFR 317.2(h) and 9 CFR 381.121) ISSUE: What are the size and location requirements for the net weight statements on packages with header labels? POLICY: The guidelines for determining the size and location of net weight statements on meat food product packages that have header labels are as follows: 1. The entire front of the package is considered the principal display panel of the package and its area is used to determine the size of the net weight statement. Print size specifications for the net weight statement specified by the regulations must be followed. 2. The net weight statement should be placed within the lower 30 percent area of the header label if no other mandatory labeling features are printed on the rest of the principal display panel of the package. If mandatory features do appear below the header label, the net weight statement must be placed within the lower 30 percent of the total area containing any mandatory information. RATIONALE: As prescribed by the regulations in 9CFR 317.2(h)(6) and 9CFR 381.121 the size of the net weight statement is dependent on the size of the principal display panel of the package. Thus the total area of the front of the package with a header label must be used to determine the size of the net weight statement. This is consistent with the requirement for all other packages. The use of header labels has been commonplace within the meat and poultry industries for years. Header labels usually bear all mandatory and other information found on the package. Because of the nature of the packaging, the area below the header label is often ideal for the placement of additional information, which is most often non-mandatory in nature. The use of this area for other information has raised questions about whether the net weight statement should then be located in the lower 30 percent of the principal display panel of the package or the lower 30 percent of the area containing the additional information, or whether the net weight statement should remain in the header label area. The regulations specify that the net weight statement should be placed on the principal display panel of the label within the bottom 30 percent of the panel, but the regulations in these situations are not clear as to what constitutes the principal display panel of the label. The regulations do specify that the principal display panel of the label should be large enough to accommodate all mandatory label information. Consequently, it is believed both reasonable and in accord with the regulations to require that in those cases where the processor has elected to place mandatory information below the header label the net weight statement must be placed within the lower 30 percent of the total area containing any mandatory information. However, it is considered unnecessary and unduly restrictive to require the relocation of the net weight statement because of the addition of non-mandatory information in the area below the header label. *A "Header Label" is a small label applied across the top of a package usually bearing all of the mandatory labeling information. The rest of the package

most often is a clear film containing a meat or poultry product such as luncheon meat. This type of packaging is designed to be used on peg board type displays.

To: Branch Chiefs, SLD

Policy Memo 048 May 18, 1982

From: Robert G. Hibbert Director SLD Subject: Level of Beef in Berliner ISSUE: What is the maximum amount of beef allowed in a sausage product called Berliner?" POLICY: "Berliner" may be made from pork or a mixture of pork and beef. When beef is used it shall not exceed 50 percent of the meat block. RATIONALE: In the past, "Berliner" was described in the Policy Book as a cooked smoked sausage usually made from coarsely cut cured pork. It could contain up to 15 percent beef. This policy has not been applied consistently to label approvals. Eight of 30 establishments which make "Berliner" have label approvals for "Berliner" which contains up to 50 percent beef. Some of these labels have been in effect for 10 years or more. It is apparent after this length of time that many consumers expect "Berliner" to contain mixtures of beef and pork up to and including as much as 50 percent beef. Therefore the maximum level of beef permitted in "Berliner" shall be 50 percent of the meat block and the Policy Book shall be corrected to show this level. A level of beef in excess of 50% would completely change the nature of the product from a pork or pork and beef product to one which is predominantly beef.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 050B December 19, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Canadian Style Bacon

ISSUE: Appropriate labeling and standards of identity for "Canadian Style Bacon"? POLICY: This replaces Policy Memo 50A on Canadian Style Bacon. Product which is identified as "Canadian Style Bacon" is made from a trimmed boneless pork loin. On the shoulder end, the cross section of the longissimus dorsi muscle shall be equal to or larger than the combined cross sectional areas of the splenius and semispinalis capitis muscles. The ham end shall be removed anterior to the illium. The exposed faces shall be approximately perpendicular with the skin surface. The dorsal and ventral side on each end of the "Canadian Style Bacon" shall not be more than 1.0 inch different in length. The belly is removed adjacent to the longissiums dorsi muscle. All bones and cartilage shall be removed. The tenderloin and the flesh overlying the blade bone are excluded. The surface fat (and false lean when necessary) shall be trimmed to 0.3 inches thick at any point. The fat on the ventral and dorsal sides is neatly beveled to meet the lean. As further clarification, the enclosed diagram (see diagram--reference hard copy of this Policy Memo) shows a cross-sectional view through the loin-shoulder separation. The area below and to the left of the perforated lines represents the "Canadian Style Bacon" with the belly, the blade bone (Scapula) and overlying flesh removed. The term "Canadian Style Bacon", when featured on the label as a product name or part of a product name (i.e. as a descriptor, etc.), may stand alone without an additional qualifier indicating the true geographical origin of the product. RATIONALE: The Issuance of Policy Memo 050 raised some questions about the identity of various muscles mentioned and the clarity of the description of the Institutional Meat Purchase Specification (IMPS) for Canadian Back. The revision of the description and the enclosed diagram are intended to provide clarification of the tissues involved. Until recently, the Division has regarded Canadian Style Bacon as a term suggesting geographical origin or charaterization, and thus has required that the true product origin be identified along with the product name (e.g. Made in U.S.A). In evaluating the connotation of the term, it has become apparent that Canadian Style Bacon is a commonplace term which is widely recognized by consumers and industry as a type or style of bacon and which holds no geographical relevance. This is best demonstrated by the various information publications which specifically identify Canadian Style Bacon as a section of the pork loin, as described above. (For diagram, see paper copy of this policy memo.)

To: Branch Chiefs, SLD

Policy Memo 051 September 13, 1982

From: Robert G. Hibbert, Director Standards and Labeling Division, MPITS Subject: Species Sausages ISSUE: The labeling and standards of sausage products labeled with species identification. POLICY: (Species) sausages identified in 319.141, 319.142, 319.144 and 319.160 of the meat inspection regulations which are also cooked, cured or smoked (or any combination) must comply with the standards before this processing if the product name is to include "(species) sausage." For example, fresh beef sausage identified in 319.142 which is cured and cooked may be labeled "cured, cooked beef sausage." Prior to this processing, these products could not contain more than the 3 percent water permitted by the standard. Cooked cured sausages or smoked cured sausages containing up to 10 percent added water in the finished product and prepared from one species may be labeled as "cooked cured sausage" or "smoked sausage" or as "cooked cured sausage made with (species)" or "smoked sausage made with (species)." Semi-dry and dry sausages made from a single species may be labeled "(species) sausage", e.g., "beef sausage." This policy does not apply to cooked sausages identified in section 319.180 of the meat regulations. RATIONALE: (Species) sausages identified in 319.141, 319.142, 319.144 and 319.160 are not permitted to contain more than 3 percent water at time of formulation. If these products are cooked, smoked or cured (or any combination), they would not be expected to contain more than the 3 percent water permitted by their respective standards. Appropriate labeling for these products would include "(species) sausage" and a description of the processing that has taken place, e.g., cured, smoked pork sausage. Certain cooked or smoked cured sausages are traditionally expected to contain up to 10 percent added water. These products are often labeled "smoked sausage" or "cured cooked sausage." If species identification is desired for these products, it is necessary that labeling be used to differentiate these products from those discussed in the preceding paragraph. The most appropriate labeling is "cured cooked sausage made from (species)" or "smoked sausage made from (species)." Since semi-dry and dry sausages are sufficiently different in appearance and character including keeping qualities, they may be labeled "(species) sausage."

To: Branch Chiefs SLD

Policy Memo 052 September 15, 1982

From: Robert G. Hibbert, Director SLD Subject: The Use of Cured Pork Tissue in Making Lard

ISSUE: May cured pork tissues be used in the preparation of lard? POLICY: Cured pork trimmings may be rendered to produce lard manufactured in compliance with the lard, leaf lard standard. RATIONALE: On June 13, 1973, the Department published in the Federal Register (38 FR 15519-20) a proposed standard for lard. The first two sentences of 319.702(a) (9 CFR 319.702(a)) of this proposed standard read as follows: (a) Lard is the fat rendered from clean and sound edible tissues from swine. The tissues may be fresh, frozen, cured, (emphasis added) cooked, or prepared by other processes approved by the Administrator in specific cases upon his determination that the use of such processes will not result in the adulteration or misbranding of the lard. This provision to allow cured tissues in these products was explained in the preamble to the proposal as follows: The principal changes proposed by the amendment in the ingredients of lard would be the authorization for use of cured and/or cooked pork tissues. This is in recognition of product processing changes that have occurred. Pork curing methods formerly involved holding pork cuts for periods of considerable length after the addition of the cure ingredients. Problems of rancidity were frequently encountered. At present, cures are added to pork cuts just prior to cooking and smoking operations. Insufficient time exists for rancidity to occur. These statements are still technically valid, and, as such, provide the basis for the allowance of cured tissues in these products. However, on October 18, 1977, the Department published a general request for data regarding the use of nitrates and nitrites in cured products (42 FR 55626-7) in order to gain further information from any interested party prior to taking any final action regarding the use of nitrates and nitrites in a variety of meat food products. At the time the final rule for lard was being developed the data received in response to this notice were being reviewed by the agency. According to the preamble to the final rule on lard published on June 13, 1978, (43 FR 25420) "since the nitrite and nitrate data have not been reviewed and other important safety issues concerning nitrosamine formation have not been fully resolved, the Department has concluded that it should withhold cured pork tissues as materials used in the production of lard, at least for the present time. As further information becomes available, the Department will reconsider its position". Therefore, the final rule did not specify cured tissues as an ingredient in lard. A review of these data and other materials has been completed. It has been shown that, because of the low temperatures at which lard is rendered, there is

little likelihood of nitrosamine formation. (J. I. Gray, "N-Nitrosamines and their precursors in Bacon: A Review", Journal of Milk and Food Technology, Vol. 39, No. 10, pages 686-692 and J.W. Pensabene et. al, "Effect of Frying and Other Cooking Conditions on Nitrosopyrrolidine Formation in Bacon"; Journal of Food Science, Vol. 39, pages 314-316). The Department has therefore determined that cured pork tissue is a satisfactory material from which to manufacture lard. Since the Department indicated in the preamble to the final rule that further action, based upon its review of the data, was contemplated, and since all cured tissues would be either cooked or fresh, categories which are both specified in the current regulation, further regulatory action does not appear necessary.

To: Branch Chiefs, SLD

Policy Memo 054 November 10, 1982

From: Robert G. Hibbert, Director, SLD Subject: Quality Control Claims (9 CFR 318.4(f) and 381.145(f)) ISSUE: What guidelines should be followed in approving labels bearing claims indicating that the product's quality is controlled or assured? POLICY: Product labels bearing claims such as "quality controlled," "quality assurance," and words of similar connotation, other than those claims specifically allowed by regulation for establishments under total quality control programs approved by the Administrator (9 CFR 381.4(f) and 381.145(f)), may only be approved under the following conditions: (l) If the claim relates to a firm's own quality control program that is not approved by USDA, the claim must indicate that the firm is responsible, e.g., "Quality Assured by Joe's Packing Company." (2) If the claim relates to a partial quality control program approved by USDA, the claim must indicate the nature of the program. The claim may include wording to indicate that the quality control program operated by the official establishment for the stated quality has been approved by USDA. An example of such a claim would be "Fat Content Quality Controlled - USDA Approved." (3) Claims approved consistent with (l) and (2) above may not be incorporated into a branding symbol, starburst, or similar design that may give the semblance of the official USDA labeling logo authorized in 9 CFR 318.4(f) and 381.145(f) for firms under total plant quality control programs approved by USDA. (4) Claims approved consistent with (l) and (2) above may not include words indicating total plant quality control, directly or indirectly, unless the establishment has an approved program authorized in accordance with 9 CFR 318.4(f) and 381.145(f). RATIONALE: The meat and poultry products inspection regulations allow processors to participate in two different quality control programs: either "Total Plant Quality Control" program for all products through all stages of preparation or a "Partial Quality Control" program for a specific product, operation, or a part of an operation. In both cases, detailed information concerning the manner in which the system will function is approved by the Administrator. The regulations (sections 318.4(f) and 381.145(f)) authorize the use of a labeling logo reading "Quality Control USDA Approved" for products prepared under a "Total Plant Quality Control" program but do not provide for a labeling logo for products prepared under a "Partial Quality Control" program. In contrast to a "Total Plant Quality Control" program, a "Partial Quality Control" program may involve only quality control of the percentage of fat declared on the product label or the nutritional information that is shown. In addition, many processors operate their own quality control programs outside the scope of the USDA approved programs. Recently, processors have submitted labeling bearing claims intended to inform consumers that their product is produced under some type of quality control program. However, the labeling may be confusing as to whether it is an official USDA approved total quality control program, a partial quality control program approved by USDA, or one operated solely by the processor. Because of this potential for

confusion and the increasing interest in the Agency's total quality control program, guidelines are necessary for approving labeling that bears phrases such as "Quality Controlled," "Quality Assured," or phrases of similar connotation to insure that they are properly qualified and not misleading.

To: Branch Chiefs SLD

Policy Memo 056 January 12, 1983

From: Robert G. Hibbert, Director SLD Subject: Potassium Sorbate and Propylparaben on Semi-Dry Sausage ISSUE: The use of potassium sorbate or propylparaben as an external mold inhibitor on semi-dry sausages. POLICY: Potassium sorbate or propylparaben may be used as an external mold inhibitor (applied by dipping or spraying) on semi-dry sausages which have a moisture-protein ratio of 3.1:1 or less and a pH of 5.0 or less. The presence of potassium sorbate or propylparaben must be declared on the label. RATIONALE: The current regulation (9 CFR 318.7(c)(4)) states that potassium sorbate or propylparaben may be used on dry sausage casings to retard mold growth and potassium sorbate may be used in oleomargarine or margarine to preserve the product and to retard mold growth. The regulation has also been interpreted to permit the use of potassium sorbate on beef jerky (letter of Irwin Fried dated July 26, 1978 and Policy Book, p. 106A). Policy Memo 17 extends this usage to imitation dry sausage products and dry beef snacks also. Semi-dry sausages having a moisture - protein ratio of 3.1:1 or less and a pH of 5.0 or less are shelf-stable. They do not require refrigeration and will not undergo microbiological spoilage at room temperature. The use of a mold inhibitor on the surface will not hide or mask interior deterioration. In this respect they are analogous to dry sausages and the use of potassium sorbate or propylparaben on the surface represents a consistent application of the regulations.

To: Branch Chiefs, SLD

Policy Memo 057A September 16, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Labeling Turkey Ham Products Containing Added Water (9 CFR 381.171) ISSUE: What is the appropriate labeling for a Turkey Ham product that contains added substances? POLICY: This Policy Memo replaces Policy Memo 057. A product otherwise conforming to the standard for Turkey Ham under section 381.171 of the poultry products inspection regulations but weighing more than the original weight of the turkey thigh meat used prior to curing shall be descriptively labeled as follows: (l) The product name must include in addition to "Turkey Ham", words that specify the amount of the additional substances, e.g., "and percent Water", "With Percent Water Added" or "Turkey Ham and Water Product Percent of Weight is Added Ingredients" (The ingredients of the added solution may be incorporated into the product name, e.g., "Turkey Ham and Water Product Percent of Weight is Added Water, Salt, Dextrose, Sodium Phosphate, and Sodium Nitrite.") The blank is filled in with a percent determined by subtracting the original weight of the turkey thigh meat from the weight of the cooked finished product. "Turkey Ham and 12 Percent Water" is an example. (2) In retail and non-retail size packaging, the qualifying statements described in (1), i.e., "With Percent Water Added", "and Percent Water," " Percent of Weight is Added Ingredients," and similar statements must be shown in lettering that is either not less than three-eighths inch in height or is at least one-third the size of the letters used in the product name, and in the same color and style and on the same background as the product name. Full length of the product labeling is not required. (3) The "Turkey Ham" portion of the product name must be qualified with the statement "Cured Turkey Thigh Meat" in the manner described in 381.171(e). This may be effected by using an asterisk as long as there is no type or other designs between the total product name and the qualifying statement. Other means of qualifying "Turkey Ham" will be evaluated based on clarity. Alternatively, the total name as described in (l) and (2) may be qualified with a statement that includes "Cured Turkey Thigh Meat" and the amount of added water, e.g., "Cured Turkey Thigh Meat and 12 Percent Water." The statement should be presented in the manner described in 381.171(e). (4) The product name shall be further qualified with the statement(s) required by section 381.171(f) and any other statement required in Part 381. A product complying with the standard for Turkey Ham, containing added substances and descriptively labeled as stated above, must be produced under a Partial Quality Control (PQC) program approved by the Processed Products Inspection Division (PPID) prior to the use of the approved label. RATIONALE: Processors using the newer cook-in films are finding it difficult to process Turkey Hams in compliance with the standard. The use of cook-in films results in a minimal amount of cooked-out juices with the excess moisture retained in the product. In addition, processors desire to provide consumers with a

product similar in compositional characteristics to hams with added water. While the poultry product inspection regulations do not yet specifically provide for a Turkey Ham containing added substances, they do provide for descriptive labeling of non-standardized products. In addition, this policy statement is consistent with the intent of labeling policies developed for various meat and poultry products containing added solutions, including those products covered under the Protein Fat Free (PFF) regulations. Labeling policies which historically have been followed for cured pork products are now being superseded by new policies accompanying the recently installed PFF regulations. Accordingly, labeling policy changes are also being made for Turkey Ham, a product which, by compositional design, closely approximates a cured pork product. One of these changes includes the lifting of the requirement that when ham products containing added solutions are placed in packages other than consumer-size, such products shall be marked with the qualifying statement the full length of the product. The new labeling policy for such additional label information no longer distinguishes consumer-size packages from those intended for non-retail uses. The other change allows the qualifying statements to be either in three eighths inch lettering or one third the size of the product name if in the same style, color and on the same background. This should provide processors with sufficient flexibility in producing a product to meet various economic and nutritional needs of consumers while still providing fully informative labeling as required by the Poultry Products Inspection Act. The need for a PQC program approved by PPID is consistent with the requirement for other similar products.

To: Branch Chiefs, SLD

Policy Memo 058A August 5, 1983

From: Robert G. Hibbert, Director, SLD Subject: Smoked Products ISSUE: What guidelines should be followed when approving labeling for product prepared with natural smoke and/or smoke flavor (natural or artificial)? POLICY: This replaces Policy Memo 058. The guidelines for approving labels for products prepared with natural smoke and/or smoke flavor (natural or artificial) are as follows: (l) Meat or poultry products which have been exposed to smoke generated from burning hardwoods, hardwood sawdust, corn cobs, mesquite, etc., may be labeled as "Smoked" or with terms such as "Naturally Smoked" to indicate that the traditional smoking process is used. (2) Meat or poultry products which have been exposed to natural liquid smoke flavor which has been transformed into a true gaseous state by the application of heat or transformed into vapor by mechanical means, e.g., atomization, may be labeled "Smoked." (See Policy Memo 040). (3) Meat or poultry products may be labeled "Smoked" if natural liquid smoke flavor is applied by spraying, dipping, liquid flooding or similar processes prior to or during heat processing. In such cases, the natural liquid smoke flavoring must be transformed into a true gaseous state by the heat of processing. (4) Meat or poultry products to which smoke flavor (natural or artificial) has been directly applied to the exposed product surface, e.g., massaging or marination, or incorporated into the product by such means as injection, must be labeled to identify the smoke flavor as part of the product name, e.g., "Ham-Natural Smoke Flavor Added" and in the ingredients statement. (5) Meat or poultry products that are smoked as provided for in (1), (2) and (3) above and also treated with smoke flavor as described in (4) may only be labeled "Smoked" or with terms such as "Naturally Smoked" as appropriate, if it is clearly disclosed that the product is also treated with smoke flavor. The presence of the smoke flavor must be identified as part of the product name, e.g., "Smoked Ham-Smoke Flavoring Added" and in the ingredients statement. RATIONALE: In the past few years, labeling policy has been developed that permits products exposed to natural liquid smoke flavor under certain specified conditions to be labeled "Smoked." However, product smoked in the traditional manner, i.e., exposed to smoke generated from burning hardwood, etc., has for many years been labeled "Smoked." Thus, the consumer cannot distinguish between a product smoked in the traditional manner from a product treated with smoke flavor unless labeling in addition to the term "Smoked" is permitted. Processors smoking products in the traditional manner, i.e., by exposing product to smoke generated from burning hardwood, etc., have expressed a desire to label such products with terms such as "Naturally Smoked" to indicate that the traditional process was used. This policy statement provides for the use of this and similar phrases for traditionally smoked products because they are appropriate and serve to provide a distinction between the traditional smoking process and the newer methods.

Present labeling policy makes a distinction between smoke flavor added to the outside of a product and natural smoke flavor that is added as an ingredient so that it becomes an integral component of the product. This policy statement is in part intended to clarify this distinction. It has been industry practice in the past to use a smoke flavoring solution to shower sausages and meat food products in casings to impart a smoke characteristic to the product during the cooking process. It is also becoming a practice to shower products that are not in casings. Since the heat of processing vaporizes the smoke flavoring which then imparts the smoked characteristic to the product, the product does not have to be labeled to indicate the presence of the smoke flavoring and may be labeled as "Smoked." However, there is a distinction to be made when the smoke flavoring solution is applied directly to the exposed product surface by such means as massaging or marination or incorporated into the product by such means as injection. In such cases, the smoke flavoring solution itself becomes an ingredient and an integral part of the product and must be declared on the labeled product. Furthermore, questions have been raised about the required labeling for products that have been smoked and also treated in some way with smoke flavor. This policy statement sets forth the need to identify the use of the smoke flavor as a qualifier to the product name and in the ingredients statement on the labeling for a product that is also smoked and labeled as "Smoked" or "Naturally Smoked." The meat and poultry inspection regulations (9 CFR 317.2(j)(3) and 381.119) already require that if a smoked flavor is added as an ingredient that the product name must be qualified to indicate its presence and be declared in the ingredients statement. Product meeting the criteria necessary to be labeled "Smoked" and to which a smoke flavor is also applied either to the exposed product surface or incorporated into the product so that it becomes an ingredient, would be misbranded if the labeling did not identify the use of the smoke flavor. Since not all of the smoke character of the product is imparted by the smoking process, the consumer would be led to believe that the product was only smoked and could not make a proper value judgment without further labeling information.

To: Branch Chiefs, SLD

Policy Memo 059 March 29, 1983

From: Robert G. Hibbert, Director, SLD Subject: Labeling Turkey Ham Products Containing Ground Turkey Thigh Meat (9 CFR 381.171). ISSUE: What is the appropriate labeling for a Turkey Ham product containing ground turkey thigh meat? POLICY: Small amounts of ground turkey thigh meat may be added as a binder in turkey ham products as defined in 9 CFR 381.171 without declaration provided the ground turkey thigh meat is made from trimmings that are removed from the turkey thighs during the boning and trimming process. The amount of ground turkey thigh meat that may be used can represent no more than the amount that was trimmed and in no case more than 15 percent of the weight of the turkey thigh meat ingredients at the time of formulation. Products containing any ground turkey thigh meat not removed during the boning and trimming processes or products containing more than 15 percent ground turkey thigh meat must be labeled to indicate the presence of the ground turkey thigh meat, e.g., "a portion of ground turkey thigh meat added." The provision in the regulations (9 CFR 381.171(f)) regarding the required use of terminology such as "Chunked and Formed," "Chopped and Formed," and "Ground and Formed" will continue to be followed. RATIONALE: Rapid advances in processing have provided the technology to prepare products with and without small amounts of ground trimmings that assume all the characteristics associated with the product. Since these products conform to public expectations, consumers may be confused or misled by terminology which seems to connote an inferior product. Total product that has been subject to mechanical reduction, such as grinding, serves to recharacterize the product in a way that is significantly different from that normally expected by consumers. Therefore, qualifiers such as "Ground and Formed" will continue to be required.

To: Branch Chiefs Standards and Labeling Division From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Corn Dogs

Policy Memo 061A September 16, 1985

ISSUE: In labeling corn dogs prepared using poultry franks, how should the kind name "Chicken" or "Turkey" be shown? POLICY: This policy memorandum replaces policy memorandum 61. "Corn Dogs" made from poultry cooked sausages such as poultry franks or poultry frankfurters must show the "kind" of the poultry used in conjunction with the coined name, "Corn Dogs" as "Chicken (or Turkey) Corn Dogs." The kind name should be shown in type size at least one-third the size of the largest letter of the coined name. A descriptive name such as "Batter Wrapped Chicken Franks on a Stick" must accompany the coined name. If the descriptive name is at least one-third the size of the coined name, the kind name need not precede the coined name. RATIONALE: "Corn Dog" or "Korn Dog" has been accepted as a coined name when followed by a descriptive name such as "Batter Wrapped Frank on a Stick." Consumers do not normally expect poultry as the main ingredient in corn dogs which have historically been prepared from red meat only. The use of poultry franks in preparing "Corn Dogs or Korn Dogs" has been increasing in popularity. The present labeling policies do not make it clear how a corn dog made with poultry ingredients should be labeled. Since these products are traditionally red meat products, prominent and clear labeling must be used when product is prepared using poultry franks. The original policy memorandum 061, which required the kind name to be the same size, did not follow previous practices in this type labeling nor did it agree with the requirements of policy memorandum 087 which stipulates one-third the size for other parts of product names on other products. The Division believes that with the use of the one-third concept the consumer will have sufficient information upon which to base his or her selection.

To: Branch Chiefs

Policy Memo 063A August 2, 1996

From: heryl Wade, Director C Food Labeling Division, Regulatory Programs Subject: Requirements for Products Identified as "Uncured" ISSUE: What are the labeling requirements for products identified as "uncured?" POLICY: This Policy Memo revises the policy stated in Policy Memo 063 by (1) rescinding the requirement to submit samples of "uncured" products for review by the Food Standards and Ingredients Branch, Product Assessment Division (PAD), as part of the label approval process, and (2) including important information regarding the identity of "uncured" products. In accordance with Title 9, Code of Federal Regulations (9 CFR), sections 317.17 and 319.2, a product, such as bacon, pepperoni, or ham, in which nitrite and/or nitrate is a required or expected ingredient, may be prepared without such cure agents when the product name is immediately preceded by the term 'uncured" as part of the product name in the same size and style of lettering. These "uncured' products must comply with performance characteristics as stated in 9 CFR 317.17(b), i.e., they must be similar in size, flavor, consistency, and general appearance to such product as commonly prepared with nitrate or nitrite, or both. However, to determine conformance with section 317.17(b) of the regulations, it is not necessary to submit a product sample for administrative review for a product-by-product evaluation as part of the prior label approval process because the product name conveys the performance characteristics expected of the uncured version. For example, an 'Uncured Beef Frankfurter' is expected to have a link form, pinkish brown color, spongy texture, and possess the flavor and aroma of a cured version made in accordance with section 9 CFR 319.180 for frankfurters and similar products. An "uncured" product addressed in 9 CFR 317.17 must have labeling features as required in 9 CFR 317.17(c), e.g., the statements "No Nitrate or Nitrite Added," and "Not Preserved-Keep Refrigerated Below 40 degrees F. At All Times," unless it has been thermally processed to destroy sporeforming pathogens; it has been fermented or pickled to pH of 4.6 or less; or it has been dried to water activity (Aw) of 0.92 or less; or contains an amount of salt sufficient to achieve an internal brine concentration of 10 percent or more. Products such as smoked sausage, which are frequently found in either the cured or uncured state, may be prepared without curing ingredients such as nitrite or nitrate. These uncured products may or may not be labeled as "uncured." However, if such a product is labeled with the term "uncured," labeling statements are required similar to those in 9 CFR 317.17 whenever the term 'uncured" is voluntarily used as part of the product name. Samples of these products for administrative review have never been required as part of the prior label review process. RATIONALE: This Policy Memo revises the policy stated in Policy Memo 063 by: (1) clarifying regulatory requirements for labeling products identified as "uncured," and

(2) discontinuing the policy of requiring submission of a product sample for evaluation by the Food Standards and Ingredients Branch, PAD, as part of the prior label approval process for uncured products subject to 9 CFR 317.17. According to 9 CFR 317.17, uncured versions of products in which nitrate or nitrite is expected or required to be added, must possess characteristics associated with the cured products. Therefore, these products must be compatible with performance characteristics expected of the cured versions, viz., they must be similar in size, flavor, consistency, and general appearance to such product as that which is commonly prepared with nitrate or nitrite. Products addressed in 9 CFR 317.17 were new at the time the regulation was promulgated, but are now common in the marketplace. Therefore, there is no longer a need for command and control, product-by-product evaluation to assure performance characteristics as stated in 9 CFR 317.17. The quality and aesthetic characteristics of uncured products are subject to the scrutiny of the marketplace as well as to Agency review during the inspection process, if the conditions of section 317.17 of the regulations are not met. As always, if questions arise regarding the regulations and policies on characterizing or expected ingredients, such as nitrite in cured products, or the lack of nitrite in uncured products, responses will be provided by the Food Standards and Ingredients Branch, PAD. Current meat inspection regulations do not specifically address the labeling of product names for products which may be found in either the cured or uncured state, e.g., smoked sausage, Linguica, and Chinese Style Sausage, when processors elect to precede the name of an uncured product with the term "uncured." This policy is designed to eliminate confusion and assure proper handling for uncured product. Samples for technical review by PAD have never been required for these products, since they retain characteristics associated with their name whether they are cured or not. However, when the term "uncured" is used as part of the product identity, it is important to include the handling statements specified in 9 CFR 317.17(c) (2) in labeling to provide consistency in identifying uncured products, help prevent temperature abuse, and to otherwise provide consumers with useful information regarding product handling.

To: Branch Chiefs

Policy Memo 066C 30 NOV 1994

From: Cheryl Wade, Director Food Labeling Division Regulatory Programs Subject: Uncooked Red Meat Products Containing Added Substances ISSUE: What are the policies for labeling uncooked (both cured and uncured) red meat products that weigh more than the weight of the fresh article? POLICY: This Policy Memo replaces Policy Memo 066B. Solutions intended to impart flavor (not extend the product) may be added in any amount to uncooked, cured and uncooked, uncured red meat products including those that have been chunked, ground, wafer sliced, etc., and formed/shaped. Whenever an uncooked, cured red meat product is injected, massaged, tumbled, etc., with a flavoring or seasoning solution, the product name must be qualified with a statement indicating that the addition of a solution has taken place, e.g., "Containing 6% of a Solution," "Injected with up to 12% of a Flavoring Solution." The qualifier must appear contiguous to the product name whenever it appears on the label. The ingredients of the solution may accompany the qualifier or appear in locations prescribed for ingredient statements. For products marinated (i.e., soaked, steeped, massaged, tumbled, or injected in order to improve taste, texture, tenderness, or other sensory attributes, such as color or juiciness) and identified as "marinated," the solution added is limited to 10 percent. The qualifying statement must include the percentage of solution contained in the product, e.g., "Marinated with up to 8% of a Solution of Water, Salt, and Sugar." In situations where it has been customary to coat a product by rubbing, spraying, or dipping water mixed with seasonings, flavorings, etc., onto the surface of the meat, the qualifying statement describing this treatment does not have to include the amount and a partial quality control program is not needed. If, however, these components are incorporated into the meat by excessive rubbing, massaging, or tumbling, a qualifying statement indicating the composition and the amount of any solution absorbed is needed as described herein. An approved partial quality control program is also needed. The addition of an enzyme solution to meat products is limited to 3 percent of the raw meat product (green weight) by the meat inspection regulations (9 CFR 318.7(c)(4)). If a product is treated with an enzyme solution and a flavoring solution, separately or in one step, both treatments must be separately identified on the label, e.g., "Tenderized with Papain," and "Marinated with up to 7% of a Solution." No particular order is required for these qualifying statements. Combined tenderization/marination solutions are limited to 10 percent of the raw meat product (green weight). For all products, the qualifying statement must be at least one-fourth the size of the largest letter in the product name. If the ingredients of the solution accompany the qualifier, they must appear in print at least one-eighth the size of the largest letter in the product name. Product name labeling prominence guidelines are found in Policy Memo 087A.

For uncooked products, the percent added substances for the label statement is determined by subtracting the fresh (green) weight of the article from the weight of the finished (total) product, i.e., after injecting, marinating, etc., dividing by the weight of the fresh article, and multiplying by 100. In all situations where the percentage of a solution is disclosed, a partial quality control (PQC) program for the addition of solutions must be approved before the label can be used regardless of the amount of solution added. Since the meat inspection regulations (9 CFR 319.101 and 102) allow uncooked corned beef brisket to contain 20 percent, and uncooked corned beef round and other cuts to contain 10 percent of a curing solution above the weight of the fresh, uncured (green weight) product without disclosure, the above labeling scheme does not apply until these levels are exceeded. If these levels are exceeded, the total amount of added solution, not just the level above compliance, must be indicated in the format described for other uncooked, cured products. Similarly, the labeling scheme does not apply to uncooked cured pork trimmings or uncooked cured pork products that are not labeled to indicate the presence of hams, loins, shoulders, butts, picnics, or cured pork made from parts not covered by the cured pork products regulation (9 CFR 319.104) until more than 10 percent added substance is present. This policy memo does not apply to uncooked cured pork products covered by the cured pork products regulation. The labeling schemes for indicating the presence of added substances in these products are outlined in the meat inspection regulations (9 CFR 319.104 and 105) and FSIS Directive 7110.2 (Rev. 1). The percentage of the weight of added ingredients is determined as described above. Cooked red meat products containing added substances are addressed in Policy Memo 084A. RATIONALE: Policy Memo 066C is generally consistent with the requirements and the intent of labeling policies now followed for uncooked red meat products containing solutions above the green weight of the fresh article. Furthermore, the need for a PQC program is consistent with past labeling policies for percentage labeling declarations. This policy issuance clarifies the labeling requirements for products to which solutions are added to impart flavor. The addition of various solutions has been approved in various uncooked red meat products. These solutions are added by various means to impart favorable flavoring and other sensory characteristics to the finished product. In the past, policies did not address the addition of solutions to all meat products and often a limit of 10 percent of the raw meat product was placed on the addition in most situations. Today, additions above 10 percent are considered appropriate, but because of the ever-changing nature of the meat products, it is necessary that these products be labeled to identify the amount and composition of solutions added to them. This policy issuance provides further guidance for compliance with 9 CFR 317.2(b). The intent of labeling prominence policy for these products is consistent with Policy Memo 087A regarding word size in labeling of product names. The labeling of qualifying statements and ingredient statements for red meat products containing added solutions is consistent with current practice. This policy is intended to clarify and update the guidelines for products that are marinated within the definition communicated in Policy Memo 081A. A declaration of the percentage of marinate solution is required in order to provide consistency with the labeling of products that are injected, massaged, tumbled, etc., and to provide consistency with poultry guidelines which also require a declaration of percentage added solution whenever poultry is marinated.

In essence, we have established that a "contains" statement, an "injected" statement, and a "marinated" statement are all satisfactory ways of disclosing the amount of added solution before cooking. This issuance clarifies the labeling requirements not previously addressed for red meat products to which an enzyme solution has been added together with a flavoring solution. This policy continues to allow the placement of ingredient statements of the added solutions in locations normally reserved for ingredient statements. The policy provides consistency with policy which permits the list of ingredients to appear on an information panel or in the case of products in cartons, on the front riser.

To: Branch Chiefs SLD

Policy Memo 068 February 9, 1984

From: Robert G. Hibbert, Director SLD Subject: Requirements for the Use of Geographic and Related Terms on Product Labels ISSUE: What are the requirements for product labels containing terms of geographical origin to be in compliance with the Federal meat inspection regulations (9 CFR 317.8(b)(1)) and the Federal poultry products inspection regulations (9 CFR 381.129(b)(2)? POLICY: Any label representation that expresses or implies a particular geographical origin of the product or any ingredient of the product shall not be used except when such representation is: 1) A truthful representation of geographical origin, e.g., "Virginia Ham" for a ham produced in the State of Virginia; or 2) A trademark or trade name which: a) has been so long and exclusively used by a manufacturer or distributor that it is generally understood by consumers to mean the product of the particular manufacturer or distributor, e.g., "Swiss Chalet"; or b) is so arbitrary or fanciful that it is generally understood by the consumer not to suggest geographical origin, e.g., "Moon Sausage"; or 3) A part of the name required or allowed by an applicable Federal law, regulation or standard, e.g., "Frankfurter", "Vienna;" or 4) A name whose market significance is generally understood by consumers to connote a particular class, kind, type or style of product or preparation rather than to indicate geographical origin of the product, e.g., "Mexican Style Dinner", "Italian Style Pizza". Such terms must be qualified with the word "style" or "type" unless specifically approved by the Administrator as a generic term, e.g., "Lebanon Bologna," "Genoa Salami," "Milan Salami". Any geographical representation that does not meet the aforementioned guidelines should be qualified by the word "brand" provided that the word "brand" is not used in such a way as to be false or misleading. A qualifying statement identifying the place where the product was actually made is required in proximity to the brand name, e.g., Milwaukee Brand Bacon, Made in Chicago, Illinois". The word "Brand" must be in the same size and style of type as the geographical term. If the product has a foreign brand name, it may be identified as having been made in this country, e.g., "Scandinavian Brand Bacon, Made in U.S.A.". RATIONALE: For many years, terms of geographical origin have appeared on the labeling of meat and poultry products. If the term has geographical significance, it is permitted under conditions specified in section 317.8(b)(1) of the Federal meat inspection regulations and section 381.129(b)(2) of the Federal poultry products

inspection regulations. This policy memorandum acknowledges that some products whose labels contain geographic references may conform to certain ethnic or cultural expectations regarding product composition, characteristics or method of preparation without necessarily being false or misleading or connoting any geographical significance to the consumer, e.g., "Mexican," "Italian". However, as the use of these features has become common and widespread, the possibility still exists for indiscriminate use of these terms which may be confusing or misleading to consumers. Accordingly, the Standards and Labeling Division is issuing these guidelines to further prescribe and define interpretations of the regulations in which terms having geographical, cultural or ethnic significance may be used. These guidelines are similar to the food and drug regulations on geographic representations (21 CFR 101.18(c).

To: Branch Chiefs

Policy Memo 069 March 23, 1984

From: Robert G. Hibbert, Director, SLD Subject: Labeling for Substitute Products ISSUE: Appropriate labeling for products which resemble and are not nutritionally inferior to standardized meat or poultry products. POLICY: If a product fails to comply with a standard only because the meat or poultry content is lower than required and the product has a generic identity as a non-meat product (e.g., pizza, stew, pies), then the product may be designated by the non-meat terminology in the standardized name (e.g., "PIZZA", "STEW", "PIE") provided the meat/poultry content of the product is conspicuously disclosed contiguous to the product name along with a statement of the amount of meat/poultry in the standardized product. For example, PIZZA (contains 5 percent sausage; SAUSAGE PIZZA contains 12 percent sausage). Such product may not be nutritionally inferior to the standardized product it resembles. For this purpose, nutritional inferiority is defined, consistent with the requirement of 21 CFR 101.3(e)(4), as any reduction in the content of an essential nutrient that is present at 2 percent or more of the U.S. RDA per serving of protein or any of the vitamins or minerals for which U.S. RDAs are established. A quality control procedure must be approved for such products by the Processed Products Inspection Division before the label can be used. If a product is nutritionally inferior to the standardized product it resembles, it must be labeled "imitation" in accordance with 9 CFR 317.2(j) and 9 CFR 381.1(b). RATIONALE: This policy allows some flexibility in developing and marketing products that may be substituted for a standardized product while maintaining the product's nutritional quality and providing labeling that better informs the public of the actual characteristics of the new products. The use of such an approach is in keeping with the Department's policy to allow descriptive labeling, in lieu of imitation labeling, for products which are not nutritionally inferior to a standardized product. The need for a quality control program is consistent with the Department's policy regarding percentage labeling.

To: Branch Chiefs, SLD

Policy Memo 072 May 18, 1984

From: Robert G. Hibbert, Director

Standards and Labeling Division, MPITS
Subject: Composite Ingredients Statement ISSUE: Can some form of composite ingredient labeling be used for a multi-ingredient component of a meat or poultry product? POLICY: This Policy Memo replaces Policy Memos 060 and 065. Processors who find it necessary to use as an ingredient a multi-ingredient product, e.g., pepperoni from various sources, each having similar but different formulations, may identify all the ingredients that may be present from all the various formulations (i.e., a composite ingredients statement). However, the ingredients identified as those that may be present can only be those ingredients that are minor in nature and cannot include ingredients such as the meat component that have a bearing on the overall characteristics or value of the product. The minor ingredients must be identified using one of the following examples of acceptable formats: l) ... pepperoni (pork, beef, water, salt, spices, sodium nitrite. May also contain lactic acid starter culture, sugar, and sodium ascorbate). 2) ... bacon bits (cured with water, salt, dextrose and/or sugar, sodium nitrite). 3) ... pepperoni (pork, beef, water, sweeteners (contains one or more of the following: sugar, dextrose, fructose, corn syrup), salt, spices, sodium nitrite). The application for label approval must identify all the ingredients of each type of component that is used so the accuracy of the composite ingredients statement can be determined. All labeling for meat and poultry products must either comply with this type of format or, alternatively, accurately list all ingredients used in the product formulation within six months of the date of this memo.

To: Branch Chiefs, SLD

Policy Memo 075 August 14, 1984

From: Joseph V. Germano/for Robert G. Hibbert, Director, SLD Subject: Dual Inspection Legends on Product Containers ISSUE: May both the meat inspection legend and the poultry product inspection legend be printed on the same product container? POLICY: Containers of products intended for sale to household consumers can bear only the official mark of inspection of the product enclosed. Containers of products intended for distribution to other than the retail trade may bear both the official meat inspection legend and the official poultry products inspection legend.

To: Branch Chiefs Standards and Labeling Division MPITS From: Robert G. Hibbert, Director Standards and Labeling Division, MPITS

Policy Memo 076 September 21, 1984

Subject: Standards and Labeling Requirements for Duck Liver and/or Goose Liver "Foie Gras" Products ISSUE: What are the standards and labeling requirements for duck liver and/or goose liver "foie gras" products? POLICY: Goose liver and duck liver foie gras (fat liver) are obtained exclusively from specially-fed and fattened geese and ducks. Products in which foie gras is used are classified into the following three groups based on the minimum duck liver or goose liver foie gras content: A) FRENCH PRODUCT NAME Foie Gras D'Oie Entier Fois Gras de Canard Entier ACCEPTABLE ENGLISH PRODUCT NAME Whole Goose Foie Gras Whole Duck Foie Gras

These are products in which goose liver or duck liver foie gras are the only animal tissues present. They may contain added substances such as seasonings and cures and when truffles are featured in the product name, they are required at a minimum three percent level. B) FRENCH PRODUCT NAME Foie Gras D'Oie Foie Gras de Canard Bloc de Foie Gras D'Oie Bloc de Foie Gras de Canard Parfait de Foie Gras D'Oie Parfait de Foie Gras de Canard ACCEPTABLE ENGLISH PRODUCT NAME Goose Foie Gras Duck Foie Gras Block of Goose Foie Gras Block of Duck Foie gras Parfait of Goose Foie Gras Parfait of Duck Foie Gras

These products are composed of a minimum 85 percent goose liver or duck liver foie gras, although "parfaits" may contain mixtures of goose liver and/or duck liver foie gras. These products may also contain a wrapping or stuffing consisting of the lean or fat of pork, veal, or poultry, pork liver, and/or aspic jelly. When these ingredients are used, their presence must be indicated in a product name qualifier. Truffles, when featured in the product name, are required at a minimum three percent level. C) FRENCH PRODUCT NAME Pate de Foie D'Oie Pate de Foie de Canard Galantine de Foie D'Oie Galantine de Foie de Canard ACCEPTABLE ENGLISH PRODUCT NAME Pate of Goose Liver Pate of Duck Liver Galantine of Goose Liver Galantine of Duck Liver

Puree de Foie D'Oie Puree de Foie de Canard

Puree of Goose Liver Puree of Duck Liver

These products must contain a minimum of 50 percent duck liver and/or goose liver foie gras and may also contain a wrapping or stuffing of the lean or fat of pork, veal, or poultry, pork liver, aspic jelly, extenders, and/or binders. When these ingredients are used, their presence must be indicated in a product name qualifier. Truffles, when featured in the product name, are required at a minimum one percent level. In all groups, an English translation of the term "foie gras" is not required, although all other product name terms must be translated into English. The kinds of poultry liver(s) used must be indicated in the product name. Also, other species and/or binders used must be indicated in a product name qualifier immediately following the product name, while the ingredient statement must follow the product name or qualifier as the case may be. RATIONALE: In 1975, representatives of the French government petitioned the USDA to adopt the French standards for foie gras products. An agreement was reached between our respective governments to follow these standards pending a rulemaking procedure. Although a rulemaking was not finalized at that time, over the years the French standards were followed and applied to foie gras products. In June of 1980, the French government and trade associations revised their 1973 standards for foie gras products and requested our renewal and approval of the new regulations. Since the standards followed over the years for the imported product have become obsolete and the marketing and consumption of these products have become more popular, SLD has decided to follow these requirements with some modifications including the English translation of French terms, the requirements for product name qualifiers, and other general policy requirements. The adoption of these requirements will eliminate confusion and provide a descriptive classification for these products.

To: Branch Chiefs, SLD

Policy Memo 077 October 11, 1984

From: Robert G. Hibbert, Director, SLD Subject: Labeling and Standards Requirements for Quiche Products ISSUE: What are the appropriate labeling and standards requirements for quiche products? POLICY: Labeling The term "Quiche" does not have to be qualified to indicate it is a custard cheese pie. However, when characterizing ingredients, such as bacon, ham, chicken, onion, etc., are used either alone or in combination, the ingredients shall be either clearly identified as part of the product name or prominently displayed elsewhere on the principle display panel (PDP) of the label (e.g., Bacon Quiche, Ham and Onion Quiche, etc.). Similarly, the characterizing ingredients in Quiches bearing fanciful names shall be identified as part of the product name or highlighted elsewhere on the PDP, (e.g., Quiche Bercy - made with ham and wine). Since "Quiche Lorraine" is widely recognized, the characterizing ingredients do not have to be identified as a part of the product name or elsewhere on the PDP. Standards Meat and poultry quiches must contain at least 8 percent cooked meat or poultry and sufficient cheese so that the combined total at least comprises 18 percent of the finished product. Quiche Lorraine must contain cooked bacon and/or ham and the only cheeses are Swiss and/or Gruyere. If other characterizing ingredients (excluding cheese) such as onions, peppers, olives, etc., are used in addition to the meat or poultry ingredient in Quiche Lorraine or in any other quiche, the combination of these other characterizing ingredients and the meat or poultry ingredients must comprise at least 8 percent of the total product and the cooked meat or poultry portion must be at least 5 percent of the total product. RATIONALE: Quiche products, with the exception of Quiche Lorraine, have been required to be labeled with descriptive terms that specifically convey to the consumer that it is a custard cheese pie. Since these products have gained widespread familiarity among consumers, the practice of including this additional information in the name of the product is unnecessary. However, it is important that other characterizing ingredients be prominently displayed to ensure that quiche products are easily identified by the consumer so that an informed choice can be made. Like the term "quiche" itself, Quiche Lorraine has been employed to the point where it can be considered a common or usual name of a product, thereby eliminating the need for this additional information. Other requirements concerning the composition for meat and poultry quiches, combination quiches, and Quiche Lorraine have been established to promote uniformity among similarly named products, and to ensure that such

products will be consistent with consumer expectations. The standards reflect longstanding requirements and the prior approval record.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 081A October 22, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Rescindment of Policy Memo 081 Policy Memo 081 is hereby rescinded. Marination may include the traditional steeping process as well as massaging, tumbling, and injection. However, the limits for solution pick-up still apply whenever marinated or similar terms appear on the label.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 082 May 2, 1985

From: Margaret O'K. Glavin, Acting Director Standards and Labeling Division Subject: Labeling of Institutional and Wholesale Type, Large, Immediate Containers ISSUE: Is it necessary that all mandatory information appear on the principal display panel of institutional and wholesale, large-size, immediate containers? POLICY: On institutional and wholesale type, large, immediate containers, all mandatory information must appear on the principal display panel except that the first usable panel to the right of the principal display panel may be used for the firm's name and address and the ingredients statement. RATIONALE: Although there may have been some deviations from the aforesaid policy in the past, sections 317.2(c) and 381.116(a) of the meat and poultry inspection regulations require the mandatory information to appear on the principal display panel of "all" labels. This would therefore include any size and type of immediate container labels. Labels not conforming to the policy should be corrected no later than January 1, 1986.

To: Branch Chiefs, SLD, TS

Policy Memo 083A May 12, 1988

From: Ashland Clemons/for Margaret O'K. Glavin, Director Standards and Labeling Division Technical Services Subject: Check-Off Blocks on Labeling ISSUE: Should check-off blocks on immediate container labeling be used for identifying products that look alike or are different in composition? POLICY: The use of check-off blocks on immediate containers for identifying products that look alike but are
different in composition is not permitted.
Examples of product that may look alike but are different in composition are as follows:
- Ground Beef and Beef Patty Mix - Partially Defatted Chopped Beef and Partially Defatted Beef Fatty Tissue - Frankfurters and Frankfurters with Variety Meats - Finely Ground Chicken and Finely Ground Chicken Meat - Comminuted Chicken and Comminuted Chicken with Kidney and Sex Glands Removed However, exceptions to this policy may be granted. Exceptions would require that the establishment operators develop a procedure which the assigned inspector can readily monitor to ensure correct labeling. Such procedures, accompanied by written comments from the assigned inspector and where possible, the circuit supervisor, must be forwarded to the area supervisor for review and approval. Approved procedures must be attached to the label transmittal forms accompanying new or modified labels submitted for approval. RATIONALE: The use of multiple check-off blocks and product names on immediate container labeling is an acceptable practice that permits the economical utilization of packaging and labeling materials by official establishments. However, consideration must be given to the potential for misbranding the product, either intentionally or unintentionally, when multiple check-off blocks are used. It is very easy for an establishment employee to check the wrong block or to forget to check any block. In such situations, our field inspectors and compliance officers are seriously handicapped in assuring the accuracy of the label. For example, the fat content of ground beef patties is limited to 30 percent while beef patty mix may contain more fat than the other. Comminuted chicken and comminuted chicken with kidneys and sex glands removed may look alike but only the latter could be used in meat sausages. Partially defatted chopped beef and partially defatted beef fatty tissues look alike but

the source materials used in processing are different and control is exercised at the point of processing. Furthermore, these products often differ widely in value. It is realized that procedures can be set up by an establishment whereby there is tight control over the packaging of end products that look alike with the assurances that the appropriate check-off block will be marked. The procedures developed must demonstrate what steps the establishment operators will take so the assigned inspector can readily monitor the product to ensure proper labeling. If the procedures are approved, they can be submitted with labels for check-off blocks for products that look alike but are different in composition.

To: Branch Chiefs

Policy Memo 084A November 30, 1994

From: heryl Wade, Director C Food Labeling Division, Regulatory Programs Subject: Cooked Red Meat Products Containing Added Substances ISSUE: What are the policies for labeling cooked corned (cured) beef products, and cooked cured pork products not addressed by the cured pork products regulation (9 CFR 319.104), and cooked uncured products that weigh more than the weight of the fresh uncured article? POLICY: This Policy Memo replaces Policy Memo 084 and includes cooked uncured products previously addressed in Policy Memo 066B. Cooked corned beef products and cooked cured pork products not addressed by the cured pork products regulation (9 CFR 319.104), that weigh more than the weight of the fresh uncured article, may be prepared if they are descriptively labeled to indicate the presence and amount of the additional substances. Acceptable product names include: "Cooked Corned Beef and X% Water" or "Cooked Cured Pork and Water Product, X% of Weight is Added Ingredients, and "Cooked Pastrami and Up to 20% of a Solution. The ingredients of the solution may accompany the product name or appear in locations prescribed for ingredient statements. Product name prominence guidelines are found in Policy Memo 087A and Policy Memo 109. If product name qualifiers, such as "X% of Weight is Added Ingredients," are used, the labeling prominence guidelines used for cured pork products as found in 9 CFR 319.104(b) apply. Uncured red meat products that weigh more than the weight of the fresh article after cooking should be labeled with a qualifying statement indicating the amount of solution remaining after cooking, e.g., "After cooking, contains X% of a seasoning solution of . . . . The ingredients of the solution may accompany the qualifying statement or appear in locations prescribed for ingredient statements. The qualifying statement must be onefourth the size of the largest letter in the product name. If the ingredients of the solution accompany the qualifier, they must appear in print one-eighth the size of the most prominent letter in the product name. Other labeling prominence guidelines are found in Policy Memo 087A. If cooked, uncured red meat products that contain added solutions/substances prior to cooking are cooked back to or below the weight of the fresh (green weight) article, words, such as "seasoned" and "flavored," are to be used to reflect the addition of the added substances, e.g., "Seasoned Cooked Beef." For cooked products, the percent added substances for the label statement is determined by subtracting the fresh (green) weight of the article from the weight of the finished cooked product, (i.e., after injecting, marinating, etc., and cooking), dividing by the weight of the finished product, and multiplying by 100. This policy is intended to apply to solutions that impart favorable flavor and other sensory characteristics, but not to solutions containing ingredients used to extend a product, such as isolated soy protein and carrageenan. A prerequisite for use of labels for these products is a partial quality control (PQC) program approved by the Food Safety and Inspection Service, as described in section 318.4 of the Federal meat inspection regulations.

Uncooked red meat products containing added substances are addressed in Policy Memo 066C. RATIONALE: Policy Memo 084A consolidates and clarifies the labeling requirements for cooked red meat products containing added solutions. These policies were previously covered by Policy Memo 084 and a portion of Policy Memo 066B. Since calculations for the percent of added solutions or ingredients depend on whether the product is cooked or uncooked, it was logical to include the policy for cooked products previously in Policy Memo 066B into the new Policy Memo 084A and revise Policy Memo 066B to address only uncooked products. Policy Memo 084A is generally consistent with the requirements and intent of labeling policies now followed for cured and cooked products containing solutions above the green weight of the fresh article. The traditional name supplemented with additional information offers the descriptive labeling necessary to distinguish these products from the traditional products. Furthermore, the need for a PQC program is consistent with past labeling policies for use of percentage labeling declarations on labeling. This policy issuance provides further guidance for compliance with 9 CFR 317.2(b). The intent of labeling prominence policy for these products is consistent with Policy Memo 087A regarding word size in labeling of product names. The labeling of qualifying statements for the cured products is consistent with Policy Memo 109 and 9 CFR 319.104(b). The labeling of qualifying statements and ingredient statements for uncured products is consistent with current practice. This policy issuance clarifies the labeling requirements for products to which solutions are added to impart flavor and are subsequently cooked. The addition of various solutions has been approved in various uncooked red meat products, including beef for further cooking, roasts, chops, and steaks. These solutions are added by various means to impart favorable flavoring and other sensory characteristics to the finished product. In the past, policies did not address the addition of solutions to all meat products and often a limit of 10 percent of the raw meat product was placed on the addition in most situations. Today, additions above 10 percent are considered appropriate, but because of the ever-changing nature of the meat products, it is necessary that these products be labeled to identify the amount and composition of solutions added to them. A differentiation must be made to avoid situations where, for example, a product that has had no solution added to it and cooked is labeled the same as a product that has had 20 percent of a solution added and cooked back to green weight. The traditional name supplemented with additional information offers the descriptive labeling necessary to distinguish these products from the traditional products. This policy issuance changes the previous requirement for a statement of solution added prior to cooking on labels of cooked, uncured red meat products. In reviewing the application of this policy, it has become evident that the use of the previously optional "after cooking" statement has increased and the use of such a statement alone will sufficiently provide the purchaser with the needed information. Thus, we are permitting the use of this statement in lieu of the "prior to" statement. In essence, we have established that a "contains" statement, an "injected" statement, and a "marinated" statement are all satisfactory ways of disclosing the amount of added solution before cooking or after cooking. Thus, if a company chooses to use two statements, i.e., before and after cooking, it is conceivable that any combination of these terms could be used.

This policy issuance also provides a change in permitted nomenclature for indicating when cooked, uncured red meat products that contain added solutions/substances prior to cooking are cooked back to green weight or below green weight. The use of words, such as "seasoned" and "flavored," as part of the product name would connote the addition of substances in processing just as "Ham" is understood to represent a product to which cure solution has been added in processing. This policy continues to allow the placement of ingredient statements of the added solutions in locations normally reserved for ingredient statements. The policy provides consistency with policy which permits the list of ingredients to appear on an information panel or in the case of products in cartons, on the front riser.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 087A September 16, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Word Size in Labeling of Product Names and Fanciful Names ISSUE: In labeling meat and poultry products, what restrictions should be placed on the size of words used in product names and fanciful names? POLICY: This clarifies and replaces Policy Memo 087. Words in product names or fanciful names may be of a different size, style, color or type, but in all cases, the words must be prominent, conspicuous and legible. Moreover, no word in a product name, i.e., a common or usual name, a standardized name, or a descriptive name should be printed in letters that are less than one-third the size of the largest letter used in any other word of the product name. The same guidelines apply to letters of words in fanciful names that may accompany the product name. For example, for a product labeled Chili Mac--Beans, Macaroni and Beef in Sauce, "Chili Mac" is the fanciful name and "Beans, Macaroni and Beef in Sauce" is the product name. No letter in "Chili Mac" may be smaller than one-third the size of the largest letter in "Chili Mac." Similarly, no letter in the descriptive name may be smaller than one-third the size of the largest letter in the descriptive name. This policy is not intended to address the relative size of words in fanciful names versus product names. The size of words in qualifying statements, e.g., "Water Added," "Contains up to ...," "Smoke Flavoring Added," etc., are not affected by this policy memo. Labeling not in compliance with these guidelines may be used until present supplies are exhausted. InspectorsIn-Charge shall determine the amount of present supplies. RATIONALE: A trend has been observed that some words within a product name, be it a common or usual name, a standardized name, a descriptive name or words within a fanciful name, are being printed with increasingly smaller letters. If this trend continues, it is likely that some words will attract disproportionate attention, causing the label to become misleading to consumers. This policy clarifies the amount of variation in letter size which will still allow some emphasis on significant words in the names of products without resulting in misleading labels.

To: Branch Chiefs, SLD

Policy Memo 088 May 23, 1985

From: Margaret O'K. Glavin Acting Director SLD Subject: The Labeling of Meat and/or Poultry Products with the Term Nuggets" ISSUE: What guidelines should be followed when approving labeling for products which includes the term "nuggets?" POLICY: This policy memo clarifies and replaces Policy Memo 067. Nuggets are irregularly shaped, usually bite-sized meat and/or poultry products, which are usually breaded and deep fat fried and intended to be used as finger foods. There are a number of different types of nuggets; the labeling for which is described below: (1) Products made from a solid piece of meat or poultry may use the term "Nugget" as part of the product name without further qualification (e.g., "Chicken Nugget", "Beef Nugget"). (2) Products made from chopped and formed meat or poultry may use the term "Nugget" as part of the product name provided a qualifying statement describing such process is shown contiguous to the product name, e.g., "Chicken Nugget, Chopped and Formed" or "Beef Nugget, Chopped and Formed." (3) Products made from chopped meat or poultry and containing binders, extenders and/or water may use the term "Nugget" as a fanciful name provided a descriptive name immediately follows "Species" or "Kind" nugget. An example of a descriptive name would be "Breaded Nugget Shaped Chicken Patties." (4) Products described in 1, 2, and 3 above which are breaded shall be labeled as "breaded" and shall be limited to 30 percent breading. RATIONALE: These nugget-type products have become increasingly popular for both retail and institutional distribution. With the increase in popularity has come an increasing number of processes and formulations. 317.2(c)(1) and 381.117(a) of the meat and poultry regulations require that if there is no published standard for a product that the name of the product is a truthful descriptive designation. Furthermore, 381.117(d) requires that boneless poultry products be labeled in a manner that accurately describes their actual form and composition. A method of labeling which differentiates the various categories of nugget products is needed. The policy stated above requires labeling which accurately describes the products and prevents unfair advantages for the different types of products. Labels not conforming to the above should be corrected prior to September 1, 1985.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 089 May 29, 1985

From: Margaret O'K. Glavin, Acting Director Standards and Labeling Division Subject: Use of the Term "Breaded" on Labels for "Fritters" ISSUE: Is it permissible to use the term "breaded" in conjunction with product name "fritters?" POLICY: The item named "fritter" may be qualified with the term "breaded" when the fritter is coated after fabrication with no more than 30 percent breading. When the term "fritter" is being used to describe the product which is coated with more than 30 percent breading, the term "breaded" may not be used. RATIONALE: The term "fritter" is generally accepted to describe (1) a product which contains breading in excess of the 30 percent allowed by 319.880 and 381.166 of the meat and poultry inspection regulations and (2) a patty like product containing breading and/or other extenders mixed with ground meat and/or poultry. In labeling the product described under (1), it is not appropriate to use the term "breaded" since in these instances, the term fritter" is being used because the "breading" limitation is being exceeded. However, product described under number (2) could also be breaded after fabrication with no more than 30 percent breading and be labeled as a "breaded fritter."

To: Branch Chiefs, SLD

Policy Memo 090B December 18, 1990

From: Ashland Clemons, Director Standards and Labeling Division Regulatory Programs Subject: Protective Coverings This replaces Policy Memo O90A. ISSUE: Under what circumstances can immediate containers be considered protective coverings? POLICY: Processed or Prepared Product - Immediate containers such as bags, cardboard cartons, tray packs, and film bags enclosing processed or Prepared product can be considered protective coverings and exempt from the marking and labeling requirements if placed in a shipping container which meets all mandatory labeling requirements of an immediate container. This does not exempt the mandatory identification and marking which is specifically required on the immediate container of cooked beef (9 CFR 318.17). In addition, the shipping container must be clearly marked "Packed for Institutional Use" or an equally descriptive statement of intended limited distribution, i.e., locations where the entire contents are consumed on the premises. Unlabeled product may not be removed from shipping containers for further distribution nor displayed or offered for sale. Unprocessed Meat Cuts - Transparent film bags enclosing individual meat cuts in an unprocessed state can be considered protective coverings and exempt from the marking and labeling requirements if placed in a shipping container which meets all mandatory labeling of an immediate container. These unlabeled meat cuts may only be removed from the shipping container for resale and further distribution to retailers, hotels, restaurants, and similar institutions if the product itself or the film bag bears a clearly legible official mark of inspection and the establishment number. If these products are repackaged or reboxed at another establishment, the official mark of inspection and the corresponding establishment number of the repackaging or reboxing company must be used unless the original producing establishment has officially, through the use of FSIS Form 7227-1 (Permit to Ship Labels between Establishments), provided their labels to the repackaging establishment. RATIONALE: The subdividing of unpackaged processed or prepared product into smaller units such as vacuum bags, cardboard cartons, and tray packs has become a popular practice as a means to promote sanitary product handling and to protect product quality. This practice, however, raises the question of whether these smaller units are immediate containers subject to the labeling or marking requirements of the Act and the regulations or are intended solely to protect the product against soiling or excessive drying during transportation and storage. Since this policy memo restricts the use of these smaller units to circumstances where they will be contained in fully labeled or marked shipping containers, these smaller units can be considered protective coverings. Cooked beef is specifically required to bear certain identification and marking on their immediate container (9 CFR 318.17). These containers must continue to bear the required information because of the trace back concerns associated with cooked beef product. Unprocessed Individual Meat Cuts in transparent containers may be distributed in protective wrappings or transparent coverings if the official mark of inspection is clearly legible on the product or protective covering.

This parallels the regulatory authority given in 9 CFR 317.1 for the use of protective coverings on dressed carcasses and primal parts. This policy memo clarifies that any repackaging or reboxing and labeling that occurs at a location other than the producing establishment is acceptable. Policy Memo 090 originally stated that the product or the film bag needed to bear a legible mark of inspection and the establishment number of the producing plant. Policy Memo 090 was not clear about which establishment number (i.e., producing or repackaging) was to be used on repackaged or reboxed products. The new phrasing of this section clarifies that it is acceptable for the establishment number of the repackaging or reboxing establishment to appear on bags of unprocessed meat cuts, or that, with the use of FSIS Form 7227-1, the labels of the original producing establishment may be used. Policy Memo O90A added a requirement, to provide consistency with processed or prepared products, that the shipping container would need a statement of limited distribution. This requirement is deleted because it is believed to be unnecessary for unprocessed meat cuts.

To: Branch Chiefs, SLD

Policy Memo 091 September 16, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Ground Beef Chuck and Ground Beef Round ISSUE: What guidelines should be followed in the review and approval of labeling for "Ground Beef Chuck" and "Ground Beef Round"?
POLICY: Product to be labeled "Ground Beef Chuck" or "Ground Beef Round" must comply with the
following guidelines:
1. "Ground Beef Chuck" must be derived from all or part of the primal part of the beef carcass commonly referred to as the "Beef Chuck" except as provided for in 3. The product must comply with the fat requirements of 9 CFR 319.15(a). 2. "Ground Beef Round" must be derived from all or part of the primal part of the beef carcass commonly referred to as the "Beef Round" except as provided for in 3. The product must comply with the fat requirements of 9 CFR 319.15(a). 3. Generally, shank meat may be added but may not exceed the natural proportion of the beef carcass, which is considered to average 6 percent. Higher quantities of shank meat may be used if the shank meat remains attached during the cutting and boning of the boneless chuck or round, or if the processor can demonstrate that a higher percentage is applicable. 4. The products must be produced under a partial quality control program. Time necessary to revise any approved PQC program or to reformulate any product as a result of this policy memo should be requested from the MPIO Regional Operations Staff. RATIONALE: These guidelines clarify the policy contained in MPI Bulletin 82-67, dated 12-22-82, titled "Ground Beef Chuck" and "Ground Beef Round." SLD has received questions such as; Are trimmings from these parts limited? Is there a fat limitation? Is shank meat limited? Should shank meat be excluded? etc. It has been an accepted practice to include as source material for product labeled "Ground Beef Chuck" or "Ground Beef Round" any portion(s) of the primal part identified in the product name. The inclusion of shank meat became an issue as a result of an established and accepted practice for producers to cut and bone the entire shank on chuck or shank on round as a single unit to formulate these products. Including the shank meat under this condition has been permitted as incidental to the boning operation although the shank itself is a primal part of the beef carcass. This policy recognizes the established practice of marketing the shank on chuck or shank on round as a single wholesale unit. Its use at higher than natural proportions of the Beef Carcass cannot however, be considered

incidental and the product must be labeled with terms such as: "Ground Beef," "Ground Beef Chuck and Shanks," or "Ground Beef Round and Shanks". Applying a 30 percent fat level ensures that during the grinding and blending of the various portions of the chuck or round that the finished product will not exceed the total fat limits allowed in other ground beef products. The partial quality control (PQC) program assures adequate identification of the source material prior to fabrication.

To: Branch Chiefs

Policy Memo 092 December 16, 1985

From: Margaret O'K Glavin, Director Standards and Labeling Division Subject: Veal Parmagiana Made with Veal Patties ISSUE: What is the appropriate labeling for Veal Parmagiana made with Veal Patties? POLICY: The labeling of Veal Parmagiana made from a veal patty shall include Veal Patty in the product name, e.g., "Breaded Veal Parmagiana made with Veal Patties" or "Breaded Veal Patty Parmagiana". The ingredients of the veal patty do not have to be a part of the product name. RATIONALE: On the label of Veal Parmagiana made with veal patties, the ingredients statement for the total product should sufficiently inform the consumer of the contents of the patty. The need to disclose the ingredients of the veal patty in a qualifying statement contiguous to the product name is not believed necessary. This additional disclosure, which has been a longstanding requirement for this product, is incongruent with the labeling for other similar meat patty products. Further, the standards of composition are even more restrictive for veal patties used in Veal Parmagiana since the minimum meat requirement specified automatically limits the level at which components such as extenders, water, beef fat, and seasonings may be added. Thus, it seems unjustified to prescribe this additional labeling requirement for this patty product when other similar, but less ingredient-restrictive patty products, are not bound by this requirement.

To: Branch Chiefs, SLD

Policy Memo 093 December 16, 1985

From: Margaret O'K. Glavin, Director Standards and Labeling Division, MPITS Subject: Adjusting for Protein Fat Free (PFF) Controlled Pork
ISSUE: What formula adjustments are necessary when using protein fat free (PFF) controlled pork to meet
minimum meat content standards in other products?
POLICY: Protein Fat Free (PFF) controlled cured pork products with qualifying statements, e.g., "Ham-Water
Added," may be used in place of PFF controlled cured pork products without qualifying statements, e.g., Ham,
to meet the minimum meat requirements of various products. However, the amounts of the PFF controlled cured
pork products with qualifying statements used will need to be increased. For example, if a standard requires a
certain amount of Ham and a processor wishes to use "Ham-Water Added," a greater amount of the "Ham-
Water Added" will be needed to meet the standard. The magnitude of the additional amount is directly related
to the relationship between the respective PFF values.
Example: Ham Salad requires 35 percent Cooked Ham. "Ham Water Added" will be used in the product
formula.
Calculation: Multiply the PFF value for Ham (20.5) by the amount of required Ham (35 percent). Divide this
answer by the PFF value of the product being used to formulate the product. (In this example PFF value for
"Ham-Water Added" is 17.0).
Answer: ((0.35 x 20.5) / 17.0) x 100 = 42.21 percent "Ham-Water Added" needed in the formula.
Example: Ham Pie requires 25 percent Ham based on green weight. "Ham with Natural Juices" will be used in
the product formula.
Calculation: Multiply the PFF value for Ham (20.5) by the amount of required ham (25 percent). Divide this
answer by the PFF value of the product being used to formulate the product.
(In this example PFF value for "Ham with Natural Juices" is 18.5).
Answer: ((0.25 x 20.5) / 18.5) x 100 = 27.70 percent "Ham with Natural Juices" needed in the formula.
ADJUSTING FOR "HAM AND WATER PRODUCT X PERCENT OF THE WEIGHT IS ADDED
INGREDIENTS."
Consider a formulated product which is required to contain at least 50 percent Cooked Ham. Suppose the
processor wishes to use a "Ham and Water Product (HWP)" in which 20 percent of the weight is added
ingredients as the source of the Ham in the formulation. This product contains 80 percent Ham and 20 percent
added ingredients. Clearly, the processor must use more than 50 percent HWP in the process. Using 50 percent
HWP would result in only 40 percent Ham in the finished product, i.e., the added ingredients in the HWP
represents 25 percent of the ham content. (If it were a 10 lb., HWP, there would be 8 lbs., of Ham and 2 lbs. of

added ingredients. (2 / 8 x 100 = 25 percent). Consequently, an additional 25 percent of HWP is required in the formulation. The following example may be used to determine the percentage HWP needed to equal Ham: Ham and Gravy requires 50 percent Cooked Ham. "Ham and Water Product 20 percent of Weight is Added Ingredients" will be used in the formulation. Step 1: Subtract the percent added ingredients from 100 percent (In this example: 1.00 - 0.20 = 0.80) Step 2: Determine the amount of Ham needed in the formula: (In this example: 50 percent) Step 3: Divide the amount of Ham required (Determined in Step 2) by the answer in Step 1 (In this example: (0.50 / 0.80 = 0.625) Step 4: Multiply the answer in Step 3 by 100. Answer for this example is 62.50 percent "Ham and 20 percent Water Product" is needed as the equivalent of 50 percent Ham. RATIONALE: In accordance with sections 9 CFR 319.104 and 319.105 of the Federal meat inspection regulations, certain cured pork products are required to meet established PFF values which reflect the minimum meat protein content indigenous to the raw unprocessed pork. Historically, most meat food product standards are based on minimum meat content requirements and reflect the definition of meat as contained in 9 CFR 301.2(tt). However, when PFF controlled cured pork products with qualifying statements are used in other products with the intention of meeting minimum meat content standards, non-meat ingredients, such as water, may alter the composition of the finished product. This policy is being adopted to assure that product standards are based on meat content requirements only. This policy memo formalizes the content of a similar memo issued earlier.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 094B December 17, 1986

From: Margaret O'K. Glavin, Director Standards and Labeling Division Subject: Sulfiting Agents in Meat and Poultry Food Products This replaces Policy Memo 094-A and will become effective 6 months from date of publication or July 9, 1987, whichever is later. ISSUE: Whether sulfiting agents present in sulfite labeled ingredients which are incorporated into meat and poultry food products need to be declared on the label of the finished product. POLICY: The presence of sulfiting agents (sulfur dioxide, sodium sulfite, sodium bisulfite, potassium bisulfite, sodium metabisulfite, and potassium metabisulfite) in or on sulfite labeled ingredients used in the preparation of meat or poultry food products must be declared on the label of the meat or poultry food product if the concentration of sulfiting agent(s) in the finished meat or poultry food product is 10 ppm or higher. However, some finished meat and poultry food products may be comprised of multiple separable components, e.g., potatoes or apple cobbler in a frozen dinner. For these products, if a separable component contains 10 ppm or more sulfiting agent(s), the sulfiting agent(s) must be declared even though the total product contains less than 10 ppm of sulfiting agent(s). When sulfiting agents are required to be declared under conditions described above, their declaration shall be according to the following: (1) Sulfiting agents shall be declared by their specific name or as "sulfiting agent(s)." (2) Declaration shall be in the ingredient statement in order of predominance or at the end of the ingredient statement with the statement "This Product Contains Sulfiting Agents" (or specific name(s)). (3) When the total product contains less than 10 ppm, but a separable component contains 10 ppm or more, the sulfiting agent must be declared as part of the component according to (1) and (2) above. RATIONALE: Sulfiting agents are not permitted as direct additives to meat or poultry food products. They may, however, be present in meat or poultry food products as the result of being present in ingredients which are used in formulating processed meat and poultry food products. Many consumers are sensitive to sulfiting agents and need to be made aware of their presence in food. The Food Safety and Inspection Service (FSIS) is requiring labeling of finished products which contain sulfiting agents so that consumers may determine the presence of sulfiting agents by reading labels rather than possibly undergoing their allergic response. These labeling requirements are similar to those required by the Food and Drug Administration (FDA) and will ensure common labeling of all food products containing sulfiting agents whether they are produced under the inspectional jurisdiction of FSIS or FDA.

To: Branch Chiefs

Policy Memo 095

Standards and Labeling Division MPITS From: Margaret O'K. Glavin, Director Standards and Labeling Division, MPITS Subject: Colored Casings-Labeling of Meat and Poultry Products

February 27, 1986

ISSUE: What are the labeling requirements for meat and poultry products in colored casings that do not transfer color to the products? POLICY: Colored casings on meat and poultry products which do not transfer color to the product, but which change and give a false impression of the true color of the products, must be labeled to indicate the presence of the casings. Acceptable terminology includes "Casing Colored" or "Artificially Colored." These phrases must appear contiguous to the product name. Casings which are the same color as the product or are not misleading or deceptive, e.g., a white opaque casing on a summer sausage, do not have to be so labeled. Also products consisting of whole muscle bundles, e.g., hams, pork butts, etc., packaged in colored wrappings where a cut surface is not visible through the casing are exempt from this labeling. RATIONALE: Under the provisions of Sections 301.2(ii)(4) and 381.1(b)(30)(iv) of the Federal meat inspection regulations and the poultry products inspection regulations, respectively, a product is considered misbranded if its container (e.g., casing) is "made, formed, or filled as to be misleading." Section 317.2(j)(8) adds "...no such casing may be used if it is misleading or deceptive with respect to color, quality, or kind of product." Therefore, for many years colored casings that changed the expected or true color of the product could only be used if the product name was clearly and properly qualified to indicate the presence of the casings. Thus the consumer could make an informed selection in the marketplace about the true nature of the product. The use of colored wrappings on whole muscle bundles is widespread apparently due to esthetic reasons. In this situation, the coloring should not mislead the consumer into believing that the product is leaner, different, or of a better quality than similar products. If a cut surface is visible, the potential for deception is a real possibility. Since there has been some confusion over the intent of this policy, this policy memo is being issued to reiterate the policy and clarify its intent.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 097 June 4, 1986

From: Margaret O'K. Glavin Director Standards and Labeling Division Subject: Label Approval Guidelines for Wild Boar Products ISSUE: What are the criteria and requirements for product labels bearing the term "Wild Boar"? POLICY: Products prepared from wild boar from feral swine are amenable and subject to the meat inspection regulations. "Wild Boar" is an acceptable label term for a product provided the words "Wild Boar" are directly followed by the statement "Meat from Feral Swine." The statement "Meat from Feral Swine" must appear prominently on the principle display panel as described in 9 CFR 317.2(d)(1)(2) and (3). If the statement "Meat from Feral Swine" does not directly follow the term "Wild Boar," then an asterisk may be included with the term "Wild Boar" and the statement "Meat from Feral Swine" should appear prominently elsewhere on the principal display panel. "Wild Boar from Feral Swine," "Wild Boar Meat* *from Feral Swine," "Wild Boar (byproduct) from Feral Swine," are also acceptable product names. In order to obtain approval for a product label bearing the name "Wild Boar from Feral Swine," or similar acceptable names, a statement describing and verifying the following physical and environmental characteristics typical of wild boar is required: color patterns such as white stripes or spots, longer bristly haircoat, elongated snout with visible tusks, a "razorback" body shape and wild boar males which are uncastrated. (We acknowledge both males and females under the term "Wild Boar.") The purchased hogs should be obtained from a nonrestrictive environment which permits foraging for uncultivated feed, natural selection and breeding and farrowing without confinement. A letter should be submitted with "Wild Boar from Feral Swine" labels describing the environment where such swine live and their method of capture or entrapment. These same criteria would also apply to imported "Wild Boar Meat from Feral Swine" and arrangements should be made through Foreign Programs for slaughter and export from approved establishments. In multi-ingredient products, such as "Beans in Sauce with Wild Boar," the "Wild Boar" part of the product name must be followed by an asterisk and a statement "(Meat or meat byproduct) from Feral Swine" must appear somewhere on the principal display panel. The ingredient wild boar, wild boar meat, or wild boar byproduct, must be listed as "Wild Boar* ((Meat or meat byproduct) From Feral Swine)" in the ingredient statement in its proper order of predominance. RATIONALE: There are an increasing number of products entering the market which purport to contain wild boar. The Agency recognizes that extensive interbreeding between domestic and European wild boar hog types occurs and thus dilutes any true wild boar line. However, the Agency recognizes that these hog crosses do have distinguishing characteristics resembling wild boar and it finds that "Wild Boar, Meat from Feral Swine" is an accurate labeling description of these hogs and the resulting pork.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 098B August 1, 1990

From: Ashland L. Clemons, Director Standards and Labeling Division Regulatory Programs Subject: Labeling and Use of Beef Cheek Meat and Beef Head Meat, and Pork Cheek Meat and Pork Head Meat ISSUE: What guidelines should be followed for the labeling and use of beef cheek meat and/or beef head meat, and pork cheek meat and/or pork head meat? POLICY: This Policy Memo replaces Policy Memo 098A. The following guidelines apply to the use and labeling of beef cheek meat and/or beef head meat, and pork cheek meat and/or pork head meat: Beef cheek meat and pork cheek meat refer to beef and pork cheeks from which the glandular material has been removed. Beef head meat and pork head meat refer to muscle tissue remaining on the beef and hog skull after removal of the skin, cheeks, tongue, and lips. The meat normally attached to and considered as part of the tongue trimmings when detached from the tongue trimmings may also be included as beef head meat or pork head meat although it can be labeled as "beef" or "pork." When beef cheek meat and/or beef head meat are included in boneless beef, their presence must be specifically declared. Examples include "Boneless Beef - Contains Beef Cheek Meat and Beef Head Meat," "Boneless Beef Head Meat," "Boneless Beef - Ingredients: Beef, Beef Head Meat, Beef Cheek Meat," or "Boneless Beef - 20 percent Beef Head Meat, 15 percent Beef Cheek Meat." Beef cheek meat and/or beef head meat may be used in unlimited quantities and identified as "beef" in meat food products unless restricted by regulatory standards for specific products as indicated in 9 CFR 319.15(a) (Chopped beef, ground beef), 319.15(b) (Hamburger), 319.15(d) (Fabricated steak), 319.81 (Roast beef parboiled and steam roasted), 319.100 (Corned beef), 319.300 (Chili con carne), 319.301 (Chili con carne with beans), and 319.303 (Corned beef hash). The presence of pork head meat is not required to be identified on the labeling of boneless pork. However, inspection personnel must not allow the use of boneless pork in Chili con carne (9 CFR 319.300) or Chili con carne with beans (9 CFR 319.301) unless they are assured of the absence of head meat or informed of the amount present. Pork cheek meat and/or pork head meat may be used in unlimited quantities and identified as "pork" in meat food products except for Chili con carne and Chili con carne with beans. RATIONALE: Policy Memo 098A set forth a policy which required the presence of pork cheek meat and/or pork head meat to be identified on the labeling of boneless pork regardless of the amount of cheek meat and/or head meat. Since that memo was issued, we have been informed that industry practice is to include pork head

meat with pork trimmings but to always ship pork cheek meat separately. In addition, since the use of pork cheek meat and pork head meat is only restricted by two regulatory standards, we believe it is an unnecessary burden to require labeling of the presence of cheek meat and/or head meat on the labeling of boneless pork. To ensure that pork head meat is not used incorrectly by a processor in restricted products, processors of Chili con carne and Chili con carne with beans must be able to verify to inspection personnel that boneless pork does not include head meat or if head meat is included in the boneless pork, the percentage of head meat present. This should ensure that regulatory limits on head meat are not exceeded in those few products where such use is limited. Since it is not industry practice to commingle cheek meat and boneless pork, problems with identification and usage do not exist.

To: Branch Chiefs, SLD

Policy Memo 099 September 2, 1986

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Labeling of Products Which Include Packets of Other Components ISSUE: What sort of product name and net weight declaration is required when meat and/or poultry products are packed with small packets of gravy, sauces, seasoning mixtures or the like? POLICY: Wording indicating that the product contains, in addition to the meat or poultry product, another component such as a gravy, sauce or seasoning packet must appear in conjunction with the name of the product in such a manner that it is obvious to the purchaser that he or she is also purchasing that packet along with the meat and/or poultry product. The wording must be shown in print no smaller than one third the size of the largest letter in the rest of the product name, of such color that will insure it not being overlooked at point of purchase, and positioned contiguous to the rest of the product name and so as not to appear in whole or part on any panel except the main display panel. The net weight statement shall show the total net weight of all the edible components. In addition to the total net weight, weights of individual components may be shown but are not required RATIONALE: The labeling of these type products must clearly demonstrate to the consumer that he or she is paying not only for a meat and/or poultry product but also for a packet or container of another component. It was brought to this office's attention that on some labels the wording announcing the inclusion of these components was being shown in sizes, colors and positions which tended to obscure it. Therefore, it was apparent that a policy needed to be developed. The one third letter size stipulated above is the same as that required for product names by Policy Memorandum 087A. Inspectors should review label approvals for these types of products and, if they believe that they do not conform to the aforementioned policy, identify them to the Standards and Labeling Division by approval number in order that all labels can be corrected no later than November 1, 1986. The requirement that the total net weight be shown is consistent with what has been required in the past for meat and poultry products.

To: Branch Chiefs, SLD

Policy Memo 100 September 3, 1986

From: Margaret O'K. Glavin Standards and Labeling Division, MPITS Subject: Poultry Tenders and Poultry Tenderloins ISSUE: When "(Kind) Tenders" or "(Kind) Tenderloins" are used as a product name, what products are being described?
POLICY: A "(Kind) Tender" is any strip of breast meat from the kind of poultry designated.
A "(Kind) Tenderloin" is the inner pectoral muscle which lies alongside the sternum (breast bone) of the kind
indicated.
RATIONALE: These terms have been used for a number of years for muscles from the breast without a clear
cut definition to distinguish one from the other. The policy stated above appears to be what is being done as
general practice. Since the Division continues to receive questions concerning these terms it is necessary that
this policy memorandum be issued to make the definitions available to all.
Previously, the word "breast" has been required to be used in conjunction with these terms. However, because
of the long usage of these terms for breast muscles only, that requirement is being dropped.

To: Branch Chiefs, SLD

Policy Memo 101A August 30. 1988

From: Ashland Clemons Acting Director Standards and Labeling Division, Technical Services Subject: Use of Quality Grade Terms and Subjective Terms on Labels ISSUE: How and when may terms which denote quality grades and certain other subjective terms be used on labels for meat and/or poultry products? POLICY: This policy memo supersedes Policy Memo 101. Terms designated as grades of meat, i.e., prime, choice, select, good, etc., may only be used on red meat which has been officially graded. However, the Standards and Labeling Division (SLD) will take no action to rescind currently approved labels which contain the word "select." Labels for new or reformulated products or new product lines will be approved in accordance with the policy for grading terms described above. Letter grades A, B, C, which are designated grades for poultry may only be used on poultry (whole birds and parts) that are officially graded, and may not be used on red meat. Although poultry grade terms (U.S. Grade A, etc.) are not allowed to be used on red meats, the terms prime, choice and select may be used on poultry (whole birds or parts), that are equivalent to U.S. Grade A. The use of a possessive, e.g., XYZ's Prime, does not relieve a company of this requirement. The use of quality grade terms on further processed meat and poultry products will be evaluated on a case-by-case basis to determine if they wrongly infer that the meat or poultry used in these products has been graded. Terms which are subjective in nature such as, but not limited to, fancy, finest, super, supreme, ultimate, premium, greatest, best, old fashioned, homestyle, hotelstyle, deluxe, special, famous, and old time may be used unqualified on labels for meat and/or poultry products. The term "selected" as well as other terms, will be considered individually by the Standards and Labeling Division, again to determine if these terms wrongly infer that the meat or poultry has been graded. RATIONALE: Historically, the Department has allowed the quality grade terms prime and choice to be used on poultry, provided it was the equivalent of U.S. Grade A. Because the new grade term "select" also conveys high quality, its use on poultry should also require that the poultry be equivalent to U.S. Grade A. Poultry grade terms are not allowed on red meats. Policy Memo 101 was in error in this regard. As explained in Policy Memo 101, the use of the possessive in conjunction with quality terms was considered unnecessary since terminology such as "best," "premium," etc., has been accepted as nothing more than advertising puffery which neither misleads nor deceives the public. Policy Memo 101 did not make it clear that the use of the possessive in conjunction with meat grading terms was not appropriate for poultry that was not the equivalent of U.S. Grade A. The use of red meat grading terms, although in the possessive, would still imply incorrectly that the poultry has been graded. In the past, the term "select" was permitted to be used on labels of meat and poultry products as a subjective term without regard to grading. Recently, the official grade term U.S. Good, designated for beef and lamb, was changed to U.S. Select for beef, consequently, the word "select" will

no longer be allowed as a subjective term. However, continued use of the term "select" will be allowed for products for which companies have obtained prior approval for labels which include the term "select." Denying these companies the use of the term "select" on these products would place unwarranted economic burdens on these companies through the loss of previous investments in advertising and labeling materials.

To: Branch Chiefs, SLD

Policy Memo 102 January 6, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: The Labeling of Products Containing Meat with Added Solutions or other Nonmeat Ingredients in Secondary Products ISSUE: What are the labeling requirements for products containing a component consisting of meat with added solutions or other nonmeat ingredients? POLICY: In those situations where meat containing an added solution, or other nonmeat ingredients, e.g., Ham-Water Added, Corned Beef and Water Product, Beef-Containing up to 10 percent of a solution, are used in secondary products in sufficient quantities to meet the minimum meat requirement without including the added solution, or nonmeat ingredients, the product name need not include any reference to the added solution or nonmeat ingredients; e.g., Corned Beef and Cabbage would be an acceptable name for a product if the corned beef portion of the corned beef and water product was present in a sufficient quantity to satisfy the 25 percent cooked corned beef requirement. The ingredients statement, however, must include nomenclature as required by the regulations or policy (see also Policy Memos 066B and 084). In this example, the ingredients statement would list "Corned Beef and Water Product-X percent of added ingredients are..." For products in which the added solution ingredient as a whole is used to meet the minimum meat requirement, the product name must include nomenclature required for the component, e.g., Beef (containing up to 10 percent of a flavoring solution) Burgundy. The ingredients statement must also include the same nomenclature for the meat ingredient. RATIONALE: Historically, most meat product standards are based on minimum meat requirements. However, in recent years the proliferation of meat ingredients with added flavoring solutions or other ingredients has resulted in processors requesting the use of these ingredients in traditional products. This policy memo identifies the approach used to label the finished products. The traditional names are considered appropriate if the finished products contain sufficient meat exclusive of the added solutions or other ingredients to meet the requirements of the standard. If the meat ingredient with the added solution or other ingredients is used to meet the standard, then it is necessary to descriptively label the secondary product to indicate to the purchaser the presence of the ingredient. In all cases, the ingredients statement must show the complete common or usual, standardized, or descriptive name of the added solution ingredient as required by the Acts and the regulations.

To: Branch Chiefs, SLD

Policy Memo 103 February 13, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Boneless, Raw or Cooked, Poultry Containing Binders ISSUE: Labeling of boneless, raw or cooked, poultry to which binders are added. POLICY: Binding agents may be added individually or collectively in amounts not to exceed 3 percent for cooked poultry products and 2 percent for raw poultry products based on total finished product. When binders are added in excess of these levels, the common or usual name of the binder or the generic term "Binders Added" shall be included in a product name qualifier; e.g., "Turkey Breast-Gelatin Added." In all cases, ingredient statement identification is required. This policy is intended to apply to binders which are used in chopped or chunked poultry products that are formed into rolls, loaves, etc., but not to binders added directly into whole muscle by injection, massaging, tumbling, etc., which then act as extenders. Processors of products with labeling not in compliance with this policy memo must make the necessary labeling changes within 6 months of the date of this policy memo. RATIONALE: The addition of binders has been approved in various boneless poultry products such as poultry rolls and loaves. Existing policies and regulations, however, do not address the labeling of boneless poultry products to which binders have been added except for poultry rolls (9 CFR 381.159). The policy stated above provides consistency with requirements for poultry rolls and reflects current practice.

To: Branch Chiefs, SLD

Policy Memo 104 February 13, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division Subject: Handling Statements on Retorted Products ISSUE: Can handling statements such as "keep refrigerated" or "keep frozen" appear on labels for products which are packaged and processed to provide safety and stability at ambient temperatures? POLICY: Handling statements may appear on labels for shelf stable product, even though such product does not have to be refrigerated or frozen, and provided the statement will accurately reflect conditions of distribution and sale. These products are to be handled in the plant as shelf stable items including incubation and condition-of-container examinations. Once the product is refrigerated or frozen for shipment, distribution, and display for sale it is to be handled as a refrigerated or frozen item. RATIONALE: Recently this office has received requests to allow handling statements such as exemplified above on these shelf stable products. Some receive a heat process sufficient to achieve stability while others are rendered shelf stable through a combination of heat and some other treatment(s) such as the addition of salt, nitrite or an approved acidulent. One firm may have products in a certain line under a certain brand name which require refrigeration or freezing and may also have products in the same line under the same brand name which are shelf stable. This could lead to mishandling by the consumer of products which require refrigeration or freezing due to the availability of similarly packaged product which would not require such special handling. Therefore, SLD will allow handling statements on retorted products even if product does not have to be refrigerated or frozen. In effect, at times, this will provide for more protection than is necessary. Product should be treated as shelf stable at the plant to assure safety and handled as refrigerated or frozen product after it leaves the plant to prevent confusion by the purchaser between these products and similar products which are not shelf stable.

To: Branch Chiefs, SLD

Policy Memo 105 April 13, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Labeling Requirements for Pump-Cured Bacon Products Treated with d- or dl-alpha-tocopherol in Surface Applications ISSUE: What are the labeling requirements for pump-cured bacon which has been surface treated with d- or dl-alpha-tocopherol? POLICY: Pump-cured bacon treated on the surface with d- or dl-alpha-tocopherol must be labeled with a product name qualifier which identifies the substances involved and the method of application. The qualifier must identify both the carrier and active substance in their order of predominance. The specific names, d- or dlalpha-tocopherol, or the term, Vitamin E, may be used in the name qualifier. Examples of acceptable name qualifiers are "Sprayed with a solution of vegetable oil and Vitamin E" or "Dipped in a solution of corn oil and d-alpha-tocopherol." The name qualifier must be contiguous to the product name and printed in a style as prominent as the product name. The type used for the statement must be at least one-fourth the size of the most prominent letter in the product name, except that the ingredients of the mixture may be in print not less than one-eighth the size of the most prominent letter in the product name. The specific name of the ingredients, dalpha-tocopherol or dl-alpha-tocopherol, and of the carrier, must be listed as such in the ingredients statement, or curing statement, as required by 9 CFR 317.2(f)(1). RATIONALE: Labeling requirements for pump-cured bacon treated with d- or dl-alpha-tocopherol applied to the surface should be consistent with other surface-treated products where product name qualifiers have been required (e.g., potassium sorbate to sausage casings, added solution statements, etc.). The processing carrier listing in the qualifier is necessary because food grade oil mixtures are not expected ingredients on bacon.

To: Branch Chiefs, FLD

Policy Memo 106A December 17, 1991

From: Ashland L. Clemons, Director Food Labeling Division Regulatory Program Subject: Poultry Bacon ISSUE: Can bacon products be prepared from poultry and, if so, how are they labeled and controlled? POLICY: This Policy Memo replaces Policy Memo 106. Bacon products prepared from poultry are acceptable. The product may be designated as (Kind) Bacon. However, a true descriptive name must appear contiguous to (Kind) bacon without intervening type or design, in letters at least one-half the size of the letters used in the (Kind) bacon, in the same style and color, and on the same color background. An example of an acceptable designation is "Turkey Bacon-Cured Turkey Breast Meat Chopped and Formed." The descriptive name can stand alone as the true product name. The weight of the finished product shall be no more than the original weight of the fresh uncured poultry. The ingredient restrictions as well as the labeling and packaging requirements that apply to red meat bacon also apply to poultry bacon. Poultry bacon is not subject to nitrosamine monitoring. RATIONALE: Traditionally, bacon products have been prepared from other than pork bellies provided the nomenclature clearly identifies the nature of the product. Examples are: "Pork Shoulder Bacon," "Bacon Squares-Pork Jowl Bacon," "Beef Bacon-Cured and Smoked Beef Plate." Furthermore, many other poultry products are present in the market place with nomenclature normally associated with red meat products, e.g., Turkey Ham or Turkey Pastrami. As a result, the policy identified is a reasonable extension of existing practice. The restrictions and controls on the finished products as well as the labeling and packaging requirements are consistent with those placed on other bacon products. The requirement for nitrosamine monitoring has been deleted because there is no evidence to support a nitrosamine problem in products that are not high in fat.

To: Branch Chiefs, SLD

Policy Memo 107 August 18, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Use of "New" and Similar Terms ISSUE: Under what conditions may the terms "new," "now," and similar declarations be used on approved labeling? POLICY: Terms such as "new," "now," "improved," and similar terms may be used within the following guidelines: 1. The terms may only be used for a period of 6 months from the date of the initial approval except as noted in 2, 3, and 4 below. 2. Extensions to the 6-month period may be granted if: a. Processors can demonstrate that production or distribution delays precluded the use of the approved labeling as scheduled. In such situations, the lost time can be restored. b. Processors can demonstrate that labeling inventory needs for the 6-month period were overestimated due to poor sales. The processors must maintain records which indicate the amount and the date the labeling was originally purchased. In this situation, up to an additional 6 months can be granted. No further extension will be considered. 3. In those situations where it is customary to distribute "new" products to various geographical regions, each geographic area may receive a temporary approval for 6 months if the processor can assure adequate controls over the segregation and distribution of the products. 4. In situations where it is customary to test market product in no more than approximately 15 percent of the intended total marketing area before total distribution begins, labeling for the test market area can receive an initial temporary approval and also be included in the 6-month temporary approval given to the labeling of the product distributed to the total marketing area. Processors must be able to assure that only 15 percent of the total market is involved in test marketing. RATIONALE: This policy memo is issued for the purpose of amending and further clarifying the use and labeling of terms such as "new," "now," and similar terms on approved labeling materials. Generally, the terms have been used on labels to indicate the introduction of a new product or new formula. In the interest of truthful labeling, however, the use of these terms has been previously limited to a 6-month period for each geographical area or location for which requests are made. Processors making such requests were held primarily responsible for controlling labeling inventories and informing inspection personnel of distribution schedules and the particular locations involved.

The firmness with which we have governed requests for approval of the terms "new," "now," and similar declarations has been viewed adversely by the regulated industry. The current 6-month policy is perceived to have a chilling effect on new product development initiatives, technological advances, and innovative marketing strategies. Since it is often very difficult for marketing managers to predict the necessary quantities of packaging supplies for test market purposes, rigid enforcement of the 6-month rule forces companies to under-order these materials or be left with expensive label inventories which must eventually be discarded or left unused. An FTC advisory opinion on the use of the term "new" in advertising follows the policy in (4) above. Therefore, in order to provide additional flexibility, our policy will be revised as stated in items (2) through (4) above, when the use of the terms "new," "now," and similar declarations are requested.

To: Branch Chiefs, FLD Branch Chiefs, PAD

Policy Memo 108B June 24, 1993

From: Ashland L. Clemons, Director Food Labeling Division Regulatory Programs Subject: Water-Misted and Ice-Glazed Meat and Poultry Products

ISSUE: What is the appropriate labeling for meat and poultry products that are protected with a thin layer of water or ice, or treated with a water-mist to prevent shrinkage during freezing? POLICY: This revises Policy Memo 108A to address the water-misting of hamburger patties, ground beef patties, and chopped beef patties to prevent shrinkage during freezing. The previous policy, outlined in Policy Memos 108A and 108, has not, heretofore, addressed water-misting of these products for this purpose. When meat or poultry products are water-misted or ice-glazed, the net weight of the product may not include the weight of the water or ice. An acknowledgment to this effect must be indicated on the label application form. A prominent and conspicuous statement must appear on the principal display panel adjacent to the product name describing that the product is protected with a water-mist or ice glaze (e.g., "Product Protected with Ice Glaze"). If the manufacturer can show that a water-mist or ice-glaze is sublimed from the unpackaged product during freezing so as not to compromise the integrity of the product's formulation or the standard with which it must comply, the labeling of the product need not bear the statements identified above. A partial quality control program to assure that such a water-mist or ice-glaze is not present in the product as sold must be approved before labels for these products are used. Regulatory standards that preclude the addition of water as a functional ingredient in formulating certain products have not changed, e.g., the addition of water to hamburger, ground beef, and chopped beef is not permitted by their respective regulatory standards in 9 CFR 319.15. Because the regulatory standard precludes the addition of water, hamburger, ground beef and chopped beef patties cannot be ice-glazed and, if there is evidence of an ice-glaze on such patties subsequent to freezing, they must be labeled appropriately to be sold in commerce, e.g., as "beef patties." However, water-misting of formed hamburger, ground beef, or chopped beef patties just prior to freezing individual patties is permitted if (1) the water applied in misting acts as a processing aid to prevent shrinkage of the patties, and (2) the misted water sublimes from the surface of the patties during the freezing process such that the weight of the patty exiting the freezer does not exceed the green weight of the patty just prior to water-misting and freezing. These conditions are assured through an adequate partial quality control program. RATIONALE: This policy has been applied to raw and cooked meat and poultry products for some time, e.g., ice-glazed poultry and water-misted (frozen) meat pizzas. In the past, there have been questions about whether water could be misted onto cooked chicken fritters to partially rehydrate the breading of the fritter if the breading plus water did not exceed the allowed amount of breading for this product. Water-misting or iceglazing of any meat or poultry product is likely to be perceived by consumers as similar in nature to ice glazing

of poultry and water-misting of meat food products prior to freezing. As such, the same labeling scheme is necessary to inform consumers about the presence of the water or ice as ingredients and the reason for the glazing. A statement adjacent to the product name, which identifies the product as water-misted or ice-glazed, is sufficient to inform consumers. In some cases, manufacturers have been able to demonstrate that a very fine water-mist is sublimed during freezing of the product. In such cases, where the water added as a mist is no longer present, the labeling scheme identified above is unnecessary; however, a partial quality control program is needed to assure the water is not present. Prior to the issuance of this policy memo, the Standards and Labeling Policy Book entry on "water-misting" prohibited water-misting of products that do not permit the addition of water, e.g., hamburger patties. However, in the case of hamburger patties that are water-misted to minimize freezer shrink, the water would be considered a processing aid because (1) it serves a function to improve processing but is removed before the patties are packaged, and (2) it is without functional effect in the finished product because it has sublimated. The classification of water-misting as a processing aid requires adequate process controls to ensure that the water does not become a functional ingredient in the product formulation, thereby conflicting with regulatory standards. A control program would ensure the weight of the individual frozen hamburger patties exiting the freezer does not exceed the weight of raw hamburger patties just prior to water-misting and freezing. The same policy is extended to ground beef and chopped beef patties because they fall under the same general regulatory standard as hamburger patties and are, therefore, similar products. Ice-glazing of hamburger, ground beef, and chopped beef patties is not permitted because the presence of an ice-glaze would violate the regulatory standard which precludes the presence of added water in these products. Such products could not be used in rework for products identified as hamburger, ground beef, or chopped beef patties and would need to be labeled with a name to which a standard does not apply or which allows the presence of added water, e.g., "beef patties."

To: Branch Chiefs, SLD

Policy Memo 109 October 8, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, MPITS Subject: Labeling Prominence Guidelines for Cured, Cooked Products with Added Substances That Do Not Return to Green Weight ISSUE: What guidelines are needed to assure the product name and product name qualifiers for cured cooked products with added substances, that weigh more than the weight of the fresh uncured article (the green weight), are prominently disclosed? POLICY: The cured, cooked products covered by sections 319.100 ("corned beef"), 319.101 ("corned beef brisket"), 319.102 ("corned beef round and other corned beef cuts"), and 319.104(a) ("cured pork products" under PFF) of the Federal meat inspection regulations; and by Policy Memos 057A ("Labeling Turkey Ham Products Containing Added Water") and 084 ("Cooked Corned Beef Products and Cured Pork Products with Added Substances"), whose weights after cooking exceed the weight of the fresh uncured article, shall bear the product name and qualifying statements on the principal display panel in accordance with the following guidelines: (l) The product name and the qualifying statements must be prominent and conspicuous. (2) The label will bear the product name on the principal display panel in lettering not less than one-third the size of the largest letter in terms commonly associated with the product name, e.g., cooked, boneless, chopped, pressed, smoked, or words which could be a part of the product name, e.g., steak, butt portion, shank portion. (3) The product name will be judged prominent if the lettering is of the same style and color, and on the same color background as that which is used for the terms commonly associated with the product name or words which could be a part of the product name (see guideline 2). If other styles, colors, and/or backgrounds are used, the prominence must be judged equal to those terms and words which could be associated with or part of the product name. (4) The product name must be distinct and separate from other label information. Thus, the product name should not be part of or embedded in qualifying phrases or descriptions that include a list of added solution ingredients. Examples of acceptable terminology are "Corned Beef and Water Product" and "Cured Pork and X % of a Solution." (5) The label for the products covered by this policy memo must also bear qualifying statements that conform to established policies on the size of the lettering in these statements in relation to product name (as outlined in Policy Memo 087A, FSIS Directive 7110.2 and Policy Memo 057A). Labels for products to which this policy memo is applicable must comply within 6 months of the date of issuance.

RATIONALE: This policy memo provides further guidance for compliance with 9 CFR 317.2(b). The intent of this policy is consistent with Policy Memo 087A, regarding word size in labeling of product names. It is becoming increasingly evident that the prominence of the product names for cured products with added solutions (e.g., "Ham and Water Product," "Ham, Water Added, " and "Cooked Corned Beef Round and X % Added Water) is not sufficient to satisfactorily identify these products to the consumer. A trend has been observed for labeling these product names with smaller letters, inconspicuous styles, and poorly contrasting colors and backgrounds. As a result, the terms commonly associated with the product name (e.g., cooked, boneless, chopped, pressed) or which could be part of the product name (e.g., steak), attract disproportionate attention, causing the label to be misleading to consumers. In addition, product names are being embedded in other label information (e.g., the ingredient statement) making them inconspicuous. A guideline is, therefore, necessary to make the pertinent labeling statements prominent.

To: Branch Chiefs, SLD

Policy Memo 110 December 8, 1987

From: Margaret O'K. Glavin Director Standards and Labeling Division, TS Subject: Perishable, Uncured Meat and Poultry Products in Hermetically Sealed Containers ISSUE: What additional requirements are necessary to obtain approval and use of final labels for certain perishable, uncured meat and poultry products packaged in hermetically sealed (airtight or impervious) containers bearing a "Keep Refrigerated" or similar statement? POLICY: Establishments seeking approval of label applications for perishable, uncured products which have received a less rigorous heat treatment than traditionally canned product (9 CFR 318 and 381, SUBPARTS G and X, respectively) must submit a sufficiently detailed processing procedure either incorporated on or attached to the FSIS Form 8822-1, APPLICATION FOR APPROVALS OF LABELS, MARKING OR DEVICE. The procedure must include a description of product formulation, method(s) of preparation, cooking and cooling temperatures, type of container, and cooking and handling instructions. Hermetically sealed containers include glass jars, metal cans, flexible retortable pouches, plastic semirigid containers, etc., that are airtight and/or impervious after filling and sealing. The policy does not apply to raw meat or poultry, cooked or roast beef, cooked poultry rolls and similar products, whole or uncut cured products, or products that are distributed and marketed frozen. However, products containing cured meat or poultry as components in combination with raw vegetables, such as pasta salads and other chilled meat/poultry meals or entrees containing raw or partially cooked vegetables, are covered under this policy, provided the above-mentioned procedural attributes are indicative of the manufacturing process. In addition, an approved partial quality control program (PQCP) is required which must address the critical points in the manufacturing process. As such, the PQCP must contain a detailed description of: ingredient storage controls, product formulation and preparation; container filling and sealing; any heat treatment (times/temperatures) applied including a description of the equipment used; any other treatments applied; cooling procedures (times/ temperatures); lot identification procedures; finished product storage conditions; inplant quality control procedures; and records maintenance procedures. The PQCP must be forwarded to the Processed Products Inspection Division (PPID) for appropriate review and approval before the product label may be used. Guidelines for development of PQCP's for these products may be obtained from PPID upon request. RATIONALE: The current trend of consumers demanding fresh, convenience foods has encouraged production of an increasing variety of ready-to-serve or ready-to-eat products packaged in hermetically sealed (airtight or impervious) containers. These recently developed products are appearing in new forms of packaging, such as flexible or semirigid pouches, plastic "cans" or bowls, trays, and shrink wrap films of the high barrier type. Some containers, such as glass jars and metal cans, have been traditionally viewed by consumers as containing shelf stable products. Also, in recent years, containers that have been commonly used

for "Keep Refrigerated" products (e.g., pouches and semirigid bowls and trays) are now being used for shelf stable products. These new developments have raised concerns that the products may be more susceptible to severe temperature abuse by distributors, retailers and consumers. Moreover, if these new "Keep Refrigerated" products are not processed in a manner that provides absolute assurance that they are free of pathogenic microorganisms, the finished products may represent a potential public health hazard. Therefore, this policy is intended to provide added assurance that official establishments producing meat and poultry products of the kind stipulated herein may continue to manufacture products that are safe. The need for an approved PQCP is consistent with previous labeling policies. In this instance, prior review of proposed processing procedures and controls by the Agency will assist establishments in producing safe and wholesome products. Processors currently manufacturing and packaging products with labeling not conforming to the provisions of this policy memo or in need of a PQCP must make the necessary adjustments within six months of the date of this memo.

To: Branch Chiefs, SLD

Policy Memo 111 June 6, 1988

From: Ashland L. Clemons Acting Director Standards and Labeling Division Subject: Labeling of Meat and Poultry Stick Items ISSUE: What is the required labeling for meat and poultry stick items, (e.g., "beef sticks," "pepperoni sticks," or "beef jerky")? POLICY: Stick items such as beef jerky, pepperoni sticks, and beef sticks must be labeled (i.e., contain the required label features as outlined in 9 CFR Parts 317 and 381, Subpart N) according to the following guidelines: (l) If sold in fully labeled bulk containers, i.e., canisters, caddies, or similar containers, stick items do not have to be fully labeled unless they are individually wrapped. This type of container cannot be reused. (2) If sold in bulk containers, i.e., canisters, caddies, or similar containers, that are not fully labeled, stick items must be fully labeled. Bulk containers such as these may only be refilled with fully labeled product. (3) If sold in small, fully labeled cartons, boxes, or similar containers (e.g., 3 oz., net weight) that are only intended for retail sale intact, stick items may be individually wrapped and unlabeled. RATIONALE: FSIS Notice 70-87 (October 15, 1987), entitled "Labeling of Meat and Poultry Stick Items," was issued in an attempt to clarify the labeling policy for meat stick products. Unexpectedly, many questions have been raised about situations that were not specifically addressed in the Notice. This policy memo is intended to address those situations as well as to clarify the intent of the Notice. The effective date of the Notice, and therefore, this policy memo, is July 15, 1988. The principal policy issue is a determination of whether the wrapping on an individually wrapped stick item is considered to be an immediate container, which requires full labeling as required by the Meat and Poultry Inspection Regulations, or is a protective covering (per Policy Memo 090). Because stick items are ideally suited by their size and typical usage to be sold individually intact, this policy clarifies that in all cases stick items in individual wrappers must be fully labeled with the exception of individually wrapped sticks in small cartons, boxes, etc., that are sold intact as a unit. In this situation, the individually wrapped sticks are considered to be in protective coverings. When "naked" sticks are sold in a canister or similar bulk packaging, the bulk packaging is the immediate container and, therefore, must be fully labeled. The policy memo also clarifies that fully labeled canisters, caddies, or similar bulk containers cannot be reused because they bear the mark of inspection and product can only be placed in such containers under Federal inspection.

To: Branch Chiefs, SLD

Policy Memo 112 June 6, 1988

From: Ashland L. Clemons Acting Director Standards and Labeling Division, TS Subject: Caramel Coloring ISSUE: How are products to be labeled when they contain caramel coloring? POLICY: Caramel coloring is considered as an artificial color. Therefore, its use where permitted, requires that the name of the product be qualified to indicate its presence, e.g., cooked roast beef-caramel coloring added. This requirement does not apply to gravies, sauces, and similar products where the use of such coloring is customary. Caramel coloring may be used on the surface of raw products, e.g., beef patties, if the name is appropriately qualified. However, caramel coloring may not be added directly to the formulation of a raw product where the caramel coloring becomes an integral part of the total product. Seasoning mixes containing small quantities of caramel coloring may be used in such products if the caramel coloring does not impart color to the finished product. If a product to which caramel coloring is added, is a component in another product, e.g., roast beef in a roast beef dinner, the name of the dinner does not have to be qualified to indicate its presence. However, the ingredients statement must include the caramel coloring. RATIONALE: Caramel coloring has long been considered as an artificial coloring by USDA as well as the Food and Drug Administration. As such, the labeling requirements parallel, for the most part, the labeling requirements for artificial colorants. Caramel coloring is an expected and usual ingredient in gravies, brown sauces, and similar products and, therefore, product name qualification is not required. Caramel coloring is not permitted in raw product other than surface application because of concerns about the proper handling and cooking of the product. The absence of a requirement for a qualifying statement in the names of secondary products is based on the belief that certain characteristics of components are more suitably disclosed in the ingredients statement.

To: Branch Chiefs, SLD

Policy Memo 113 June 24, 1988

From: Ashland L. Clemons, Acting Director Standards and Labeling Division Technical Services Subject: Labeling of Products Which Are Artificially Colored ISSUE: How should products which are artificially colored be labeled?

POLICY: Labels of products which are artificially colored either by artificial colors or natural colors must bear a statement to indicate the presence of the coloring, e.g., "artificially colored" or "colored with annatto." Products whose true color is disguised by packing media, e.g., colored pickling solutions, must also have labels that include a statement that indicates the presence of the color. The statement must appear in a prominent and conspicuous manner contiguous to the product name. Products which have a component, e.g., breading, sauce, sausage, etc., that is artificially colored, do not have to have names that are qualified to indicate the presence of the color. However, in all cases, the presence of the coloring must appear in the ingredients statement. Whenever FD&C Yellow No. 5 is used, it must be declared in the ingredients statement by FD&C Yellow No. 5 or Yellow 5. Some products, e.g., chorizos and some of the sausages of the longaniza variety, are expected to be characterized by coloring. In these situations, the presence of the coloring need only be indicated in the ingredients statement. Also see Policy Memo 112 on caramel coloring and Policy Memo 095 on colored casings. RATIONALE: Both the Meat and Poultry Inspection Regulations speak to the labeling required whenever "product" contains or bears coloring. The intent of the regulations is clear, viz, that the presence of coloring that misleads or deceives the purchaser into believing that a product is of a different color, quality, or kind than expected must be indicated by a statement. However, it is apparent that the regulations never envisioned the variety of products or the ever changing character of the products available to today's consumer. Thus, the regulations are not explicit about the labeling required for products that have as a component a product that is colored. This policy memo is issued to clarify when it is necessary that the product name be qualified and to make it clear that in all cases the presence of the coloring must be declared in the ingredients statement. The policy memo adopts the belief that the product name does not need to be qualified to indicate a characteristic of a component and that the ingredients statement is the most appropriate place to disclose component information. This approach is also used for many other situations. The specific declaration for FD&C Yellow No. 5 is in accordance with the requirements of the Food and Drug Administration.

To: Branch Chiefs

Policy Memo 114A August 18, 1994

From: Cheryl Wade, Director Food Labeling Division Regulatory Programs Subject: Point of Purchase Materials ISSUE: To establish guidelines for use of point of purchase promotional materials for meat and poultry products. POLICY: This Policy Memo supersedes Policy Memo 114. Point of purchase materials which refer to specific meat or poultry products are considered labeling under certain circumstances. When printed and/or graphic informational materials (e.g., pamphlets, brochures, posters, etc.) accompany or are applied to products or any of their containers or wrappers at the point of purchase, such materials and the claims that they bear are deemed labeling and they are subject to the provisions of the Federal Meat Inspection Act and the Poultry Products Inspection Act. Although the Food Labeling Division (FLD) does not exercise its authority to subject point of purchase materials to specific prior approval (materials shipped with the products from the federally inspected establishment are an exception), we do expect point of purchase materials to be in accordance with the Federal regulations and all current labeling policies. Upon request, FLD will review and comment on the point of purchase materials submitted to our office. During the review process, promotional materials will be scrutinized for special claims, particularly those related to nutrition, diet, and animal husbandry practices. Claims related to nutrition and diet must be made in accordance with all current nutrition labeling regulations. Continuing compliance with stated claims will be assured through periodic sampling, as necessary. claims are expected to be within the compliance parameters identified in the nutrition labeling regulations. Animal husbandry claims (e.g., the nonuse of antibiotics or growth stimulants) may be made only for products shipped in containers or wrappers labeled with the same animal production claims. RATIONALE: Historically, point of purchase materials generally consisted of printed and/or graphic literature located in close proximity to a product at the retail counter. However, the nature of promotional materials which bear claims about specific products has broadened and presently includes materials which adhere directly to a package, are inserted into a package, or enclose an entire product as it is sold to the consumer. Since such point of purchase materials are deemed labeling and subject to the provisions of the Federal Meat Inspection Act and the Poultry Products Inspection Act but have not been reviewed for prior label approval, a process is still needed by which the accuracy of the information presented to the consumer can be substantiated. In the case of animal husbandry claims, accuracy is best assured if labeling bearing the same claims has been granted prior approval and is subject to the monitoring procedures available through the authority of prior label approval. Without review for prior label approval, virtually no practical methods exist to assure accuracy.

The nutrition - labeling regulations, effective July 6, 1994, differ dramatically and, in many cases, are far more restrictive than previously published nutrition labeling policies. It is important that nutrition-related information included in point of purchase materials comply with the new nutrition labeling regulations. As before, analytical sampling offers a means of assuring the accuracy of the stated nutritional claims.

To: Branch Chiefs, SLD

Policy Memo 116 July 11, 1988

From: Ashland L. Clemons, Acting Director Standards and Labeling Division Subject: Canadian Style Bacon Made With/From Pork Sirloin Hips ISSUE: What is the appropriate labeling for a Canadian Style Bacon product made exclusively from, or which includes, the sirloin end or hip portion of pork loins? POLICY: This Policy Memo does not replace Policy Memo 050B. Rather, it establishes new identity standards for Canadian Style Bacon products (l) made exclusively from the sirloin hip portion of a pork loin, or (2) which include the sirloin hip portion of a pork loin in addition to the portion of the pork loin that has traditionally been used to prepare Canadian Style Bacon (see Policy Memo 050B). The sirloin is obtained by removing a 5 to 7-inch section of the pork loin immediately in front of the hip or pelvic bone. The sirloin hip is obtained by removing the half of the sirloin which comprises the posterior end of the pork loin. The tenderloin is not included and surface fat shall be trimmed to 0.3 inches in thickness. The sirloin hip portion of the pork loin is shown in the enclosed illustrations. The area to the right of illustration 4, after the perpendicular line, represents the sirloin hip. The labeling for these Canadian Style Bacon products must bear a qualifying statement, adjacent to the product name, clarifying that pork sirloin hips are included or that the product is made entirely from pork sirloin hips, e.g., "Canadian Style Bacon -- Includes Pork Sirloin Hips" or "Canadian Style Bacon--Made from Pork Sirloin Hips." The qualifier should be printed such that the smallest letter in the qualifier is not less than one-third the size of the largest letter used for the product name, and be of equal prominence to the product name. Chunked (or chopped) and formed varieties, and substances controlled by the protein fat free (PFF) regulation for cured pork products (9 CFR 319.104) shall be labeled in accordance with applicable guidelines. RATIONALE: Several months ago, the Division informed all Canadian Style Bacon producers that they could no longer manufacture a product labeled as such for which formulation included the use of pork sirloin ends or hips either attached or detached from the pork loin. Based on information received over the past several months, and in view of current industry practices and available processing technology, we have decided to establish separate standards of identity for Canadian Style Bacon products which include, or are made exclusively from sirloin ends of pork loins. This policy is consistent with previous decisions to allow bacon to be labeled in novel ways, provided the name of the product is appropriately qualified to identify the source of the cut, e.g., "Beef Bacon -- Smoked Cured Beef Plate," or "Pork Shoulder Bacon." In addition, because of the long history of pork sirloin hips not being included in Canadian Style Bacon, product which includes the sirloin hip should be labeled in such a way that consumers are aware that this product is somewhat different from the traditional Canadian Style Bacon. The letter size and prominence requirements for the qualifying statement are consistent with other labeling prominence requirements as identified in Policy Memos 87A and 109.

Enclosure Pork Loin Pork loins are cut numerous ways. The four most commonly used methods in the U.S. are shown in the following illustrations. 1. Loin Roasts--Center Chops (For illustration, reference hard copy of this Policy Memo) In this method of cutting, a blade or bladeless loin roast containing from 5 to 7 ribs and a 5 to 7-inch sirloin roast are removed. 2. Portion Pieces--Center Chops (For illustration, reference hard copy of this Policy Memo) From 8 to 10 ribs are left in the rib portion while the sirloin is cut from 8 to 10 inches in length. 3. Whole or Half Loins (For illustration, reference hard copy of this Policy Memo) The loin is divided as nearly in the middle as possible. This leaves 2 or 3 ribs in the sirloin half. 4. Center Loin or Strip Loin (For illustration, reference hard copy of this Policy Memo) The blade loin roast is removed by cutting immediately behind the blade bone usually between the 3rd and 4th ribs of the loin. The sirloin roast is cut off immediately in front of the hip bone. As indicated by the previous illustrations describing the four basic methods of cutting pork loins, the retailer can merchandise a pork loin many different ways. Consequently, the names of retail cuts from the pork loin are often confusing. Depending on the section of the country, a center loin chop may be a loin chop or rib chop. End cut chops may either be sirloin chops or loin blade chops. The fact that the loin includes all of the rib and short loin and parts of the sirloin and shoulder does not simplify matters, either.

To: Branch Chiefs, SLD

Policy Memo 117 August 30, 1988

From: Ashland L. Clemons, Acting Director Standards and Labeling Division Technical Services Subject: Smoke Flavoring ISSUE: What are the labeling requirements for products containing a component to which smoke flavoring has been added? POLICY: The use of smoke flavoring (natural or artificial) in a component of a meat or poultry food product, e.g., ham in a ham salad, does not require that the product name be qualified to indicate the presence of the smoke flavoring. However, the smoke flavoring must be declared in the ingredients statement on the meat or poultry product labels. RATIONALE: The Meat and Poultry Inspection Regulations, 9 CFR 317.2(j)(3) and 381.119, require that when an approved artificial smoke flavoring or an approved smoke flavoring is added as an ingredient in the formula of a meat and/or poultry food product, the presence of the smoke flavoring must be shown contiguous to the product name and listed in the ingredients statement. The Meat and Poultry Inspection Regulations, however, do not explicitly address whether this requirement applies to smoke flavoring which is an ingredient of a component that is used in a meat food product or poultry food product (secondary product). Because of the absence of clarity in the regulations, confusion and inconsistency in the approval of labeling has resulted over the years. We see no useful purpose in requiring a qualifying statement in the name of the secondary product. The presence of the smoke flavoring in the ingredients statement will provide the necessary information to those consumers who are interested in knowing if a component has been treated with smoke flavoring. We believe this requirement is sufficiently informative and does not in any regard misrepresent the meat and/or poultry food product to consumers. This policy is consistent with current policy for labeling secondary products and is intended only to clarify the procedures already being implemented by the Division.

To: Branch Chiefs, SLD

Policy Memo 118 October 31, 1988

From: Ashland L. Clemons, Acting Director Standards and Labeling Division Technical Services Subject: Use of the Terms "Extra" and "More Than" ISSUE: Under what conditions may the terms "extra" or "more than" be declared for components of meat and poultry products on approved labeling (e.g., "extra tomatoes," "extra topping," "more (meat) than...")? POLICY: The terms "extra" or "more (component) than" may be used provided the following guidelines are followed: (l) There is at least a 10 percent increase in the particular component of interest over the amount that is found in the usual or "regular" formulation. (2) Information must be provided with the label application that compares the product formulation containing the "extra" amount of the component to the regular formulation of the same product to establish that at least a 10 percent increase in the component has occurred. Therefore, the usual or "regular" formulation would need to accompany submittals for "extra" or "more than" component claims at the time of label review so that the necessary comparison of formulations can be made. (3) In the situation where production of the "regular" product formulation ceases the "extra" or "more (component) than" product labels would be given a 6 month temporary approval. (4) A comparison to a similar product on the market may be made to support the "extra" or "more/than"type claim provided suitable market basket data are submitted with the label application that establish the similarity of formulations and show the increased amount of the component over the "usual" amount. RATIONALE: This policy memo is issued for the purpose of clarifying the use of the terms "extra" and "more (component) than" on approved labeling materials. There has been an increased general use of these terms in marketing strategies to connote the addition of more than the usual amount of one or more components of a product formulation. However, the use of these terms has been without a defined minimum additional amount over that which is found in a "reference" formulation. Furthermore, there has not been consistency in comparison to formulations of the same type of product (e.g., a sauce with meat to another sauce with meat). This situation has resulted in a confused processor and consumer perception as to what makes a component of a formulation "extra." Therefore, a minimum percentage above a reference to a "regular" formulation is required. The minimum 10 percent figure is consistent with the current policy for allowing declarations that a product has a greater amount of a component than another, e.g., claims of "significant" nutrient value as per 21 CFR lOl.9(c)(7)(v).

In the situation where production of the "regular" product formulation ceases, the "extra" or "more (component) than" product label would be handled as are products that contain "new" on the label; a 6 month temporary approval can be granted. Processors whose approved labels contain the above captioned declarations and fall under the purview of this policy memo must comply with its requirements within 6 months from the date of issuance.

To: Branch Chiefs Standards and Labeling Division

Policy Memo 119 September 28, 1989

From: Ashland L. Clemons, Director Standards and Labeling Division Technical Services Subject: Labeling of Safe Thawing Instructions on Consumer Packages ISSUE: What guidelines should be followed when thawing instructions for frozen meat and poultry products appear on a label? POLICY: Thawing instructions which appear on the label of a frozen meat or poultry product must be given in accordance with FSIS' recommendations for safe thawing procedures. These procedures are as follows: 1. Thawing product in the refrigerator. 2. Thawing product in cold water, changing water every 30 minutes until product is thawed. 3. Thawing product in a microwave oven for less than two hours. Cook immediately. Upon request, alternative thawing procedures may be considered. However, scientific evidence which thoroughly establishes the safety of an alternative thawing procedure must be presented with the procedure when it is submitted for review. RATIONALE: Consumer interest concerning the safe handling of meat and poultry products has prompted some manufacturers to voluntarily include thawing instructions on the labels of frozen meat and poultry products. However, consumer inquiries about these instructions, as well as information derived during the label review process, indicate that the information provided sometimes reflects thawing procedures that FSIS considers unsafe (i.e., thawing at room temperature, or at room/refrigerator temperature combinations). As a result, this policy will establish guidelines which will help to ensure that the thawing instructions included on a label adequately reflect procedures which are in accordance with FSIS safe food handling recommendations.

To: Branch Chiefs, SLD

Policy Memo 120 August 1, 1990

From: Ashland L. Clemons, Director Standards and Labeling Division Regulatory Programs Subject: Sausage Type Products with Fruits and Vegetables ISSUE: What are the standards and labeling requirements for sausage type products that contain unexpected ingredients, such as fruits, vegetables, wild rice, or nuts? POLICY: Sausage type products that contain unexpected ingredients that significantly alter the character of the product may be descriptively labeled as "(characterizing ingredient) Sausage," e.g., "Cherry Pecan Sausage" or 'Wild Rice Sausage," or with other equally descriptive names such as "Sausage with Wild Rice." For fresh sausages, the sausage portion of the product, prior to the addition of the characterizing ingredient(s), must meet any applicable standards including fat and added water limitations, moisture/protein ratios, and use of binders and extenders. For cooked, smoked, dry, etc., sausages, the finished sausage type product must meet any standard that was applicable to the sausage prior to the addition of the characterizing ingredients. The unexpected ingredient must be present in sufficient quantity or form to characterize the sausage type product in flavor, texture, or other sensory attributes. However, there are no minimum use levels. This policy applies to products containing unexpected food ingredients, e.g., fruits and vegetables, such as cherries, pecans, tomatoes, etc., that change the character of the product by the addition of unique flavor and other sensory characteristics. The policy does not apply to imitation products, i.e., products formulated to resemble in taste, texture, color, etc., the traditional sausage products, but which are nutritionally inferior. Sausages containing cheese are addressed in Policy Memo 010 and Potato Sausages are addressed in Policy Memo 011. RATIONALE: The need to formally define the standards and labeling requirements for sausage type products which contain certain unexpected ingredients, such as apples, figs, jalapeno peppers, pecans, wild rice, etc., that significantly alter the character of the product, has been made evident by the recent proliferation of requests from industry for approval of labeling for these products. Since these sausage type products do not have either a standardized name or a common or usual name, they are given a descriptive product name. We believe that a name such as Cherry Pecan Sausage, for example, satisfies the intent of the regulations in providing a fully descriptive product name. Since, in sufficient quantities, the ingredients, e.g., cherries and pecans, serve to characterize the flavor and other sensory characteristics of the product, they are appropriately given prominence in the product name. Furthermore, since these characterized sausage type products are truly new products rather than imitations of traditional products, they do not require imitation labeling.

Limitations such as fat, added water, binders, etc., are handled differently for fresh sausage products versus cooked, smoked, etc., sausage products, i.e., formulation versus finished product analysis. Likewise, such limitations for sausage type products with unexpected characterizing ingredients will also be handled differently depending on whether the finished product is fresh or cooked, etc. No minimum use levels have been established since, for example, it would take less of an ingredient, such as jalapeno peppers, than apples to characterize the product. However, if use levels are questionably small or processing procedures are vague, e.g., it is unclear whether the wild rice is ground or whole, samples may be required to verify that the ingredient is actually characterizing the product as opposed to extending the product and, thus, imitating traditional sausages. This labeling is similar to the labeling for Italian sausage with tomatoes, garlic bologna, and cheesefurters where tomatoes, garlic, or cheese characterize the product.

To: Branch Chiefs

Policy Memo 121B January 20, 1995

From: Cheryl Wade, Director Food Labeling Division, RP Subject: Labeling of Modified Substitute Versions of Fresh (Species) Sausage, Hamburger or Ground Beef Products with Added Ingredients Used to Replace Fat that Qualify for Use of Certain Nutrient Content Claims Associated with a Reduction in Fat Content ISSUE: This policy allows modified versions of fresh (species) sausages, ground beef, or hamburger to contain non-meat or poultry, "fat-replacing ingredients" (e.g., binders such as carrageenan, modified food starch) and to be identified by certain nutrient content claims in accordance with nutrition labeling regulations effective on August 8, 1994, in conjunction with descriptive labeling, e.g., "Lean Pork Sausage with a X% Solution of ...," or "Low Fat Ground Beef, Water, and Carrageenan Product." This policy allows for the use of terms defined in regulations, e.g., "Lean," "Reduced Fat," "Low Fat," etc., to be used to describe fresh (species) sausage, ground beef, or hamburger products with a reduction in fat content resulting from the use of added ingredients (i.e., "fat replacers" such as carrageenan and isolated soy protein). These products must meet the criteria for use of the nutrient content claim associated with the fat reduction. The nutrient content claim may be used in conjunction with the standardized name provided the consumer is informed of the actual components of the product through labeling, i.e., descriptive product name, ingredients statement, and Nutrition Facts. Meat products, including those that meet the criteria established for claims, such as "Lean," "Low Fat," "Lower Fat," "Reduced Fat," etc., that combine fresh (species) sausage, ground beef, or hamburger, and other safe and suitable ingredients, for the principal purpose of replacing fat, may be descriptively labeled. Examples of such products are "Lean Ground Beef, Water, and Carrageenan Product," "Low Fat Ground Beef With a X% Solution of ...," "Lean Beef Sausage, Water, and Carrageenan Product," or "Reduced Fat Pork Sausage, Water, and Binders Product," provided conditions prescribed in the regulations, viz., 9 CFR 317, for use of the nutrient content claim are satisfied. In contrast, modified versions of fresh (species) sausage, ground beef or hamburger product containing added ingredients that do not qualify for use of a nutrient content claim prescribed in the nutrition labeling regulations must be labeled as Imitation Pork Sausage, Imitation Beef Sausage, Imitation Ground Beef, Imitation Hamburger, Beef Patty or Beef Patty Mix in accordance with 9 CFR Section 317.2(j)(1) and Sections 319.141 (Fresh pork sausage), 319.142 (Fresh beef sausage), and 319.15 (Miscellaneous beef products), respectively. Descriptively labeled, modified, substitute versions of fresh (species) sausage, ground beef, or hamburger product with a reduction in fat content must comply with the following guidelines: (1) The descriptive name of a modified, substitute product with a reduction in fat content is the applicable nutrient content claim used in conjunction with the appropriate standardized name and fat-replacing ingredients, e.g., "Low Fat Ground Beef, Water and Carrageenan Product," or "Lean Pork Sausage with a X% Solution of Water, Modified Food Starch, Spices, and Salt." Words in the descriptive name may be of a different size, style, color, or type but, in all cases, the words must be prominent, conspicuous, and legible. Moreover, no

word in the descriptive name should be printed in letters that are less than one-third the size of the largest letter used in any other word in the descriptive name. The solution statement, when used, is considered to be part of the descriptive product name and must comply with descriptive name sizing requirements. (2) Fat-replacing ingredients (e.g., binders and water) and fat in the finished product may not exceed 30 percent of the product as formulated for the modified, substitute ground beef, hamburger, or fresh beef sausage product, and no more than 40 percent of the product formulation for the substitute fresh pork sausage. The fat content must be in accordance with requirements for use of the applicable nutrient content claim. (3) The product includes mandatory nutrition labeling prescribed in the meat inspection regulations, viz., 9 CFR 317. (4) The product is formulated with approved safe and suitable ingredients, e.g., those identified in 9 CFR 318.7(c)(4), and which are determined to be safe and suitable by the Food Standards and Ingredients Branch, Product Assessment Division, that are used at the lowest level necessary to achieve the intended effect as a fatreplacing ingredient (i.e., binder). (5) If percentage labeling is included as part of the product name, e.g., "Extra Lean Ground Beef With a X% Solution of ...," a Partial Quality Control (PQC) program for the addition of solutions must be approved before the label can be used. RATIONALE: Advances in food processing technology have encouraged development of an increasing array of processed meat and poultry products with a reduction in fat content demanded by todays consumers. These modified products are intended to assist consumers in meeting the nutritional goal of reducing fats in their diets. This policy allows flexibility for developing and marketing meat products with reduced fat content that may be substituted for fresh (species) sausages, ground beef and hamburger while maintaining the products nutritional quality. This policy memo (1) replaces PM 121A to conform with nutrition labeling regulations, (2) extends the previous policy to include fresh (species) sausages (i.e., sausages that are not expected to contain added ingredients, such as binders, and are generally considered by consumers to be similar to hamburger and ground beef), (3) establishes labeling requirements that inform the consumer of the actual constituents of the product, and (4) conforms with the Departments policy on descriptive labeling. Previously, PM 121A allowed ground beef or hamburger to contain added ingredients to replace fat provided the substitute products had no more than 30 percent of a combination of fat and added substances and no more than 10 percent fat and were labeled with the term Low Fat in conjunction with the standardized name and the identification of the added ingredients, e.g., Low Fat Ground Beef, Water, and Carrageenan Product. Most ground beef or hamburger combination products produced in accordance with PM 121A will not qualify to use the term low fat, now defined in the regulations, viz., 317.362. However, many of these substitute products will qualify to use the term lean, and some may qualify to use other nutrient content claims associated with meat products with a reduction in fat content. The Agency believes that it is in the best interest of both the consumer and industry to provide for labeling of modified, substitute ground beef and hamburger products containing added ingredients used to replace fat that meet the criteria for use of nutrient content claims for products with a reduction in fat contents. Moreover, the Agency believes that extending PM 121B to include modified versions of fresh (species) sausages with a reduction in fat content will encourage development of fresh (species) sausages with improved nutritional profiles.

This policy differs from the Food and Drug Administrations (FDA) regulations for modified substitute foods (21 CFR 130.10) and from PM123 which addresses modified substitute breakfast sausage, cooked sausage, and fermented sausage products in that unexpected ingredients (i.e., fat-replacing ingredients such as water and binders) are identified in the descriptive product name. The Agency believes this difference is justified because binders have not historically been allowed in the subject products formulations. Therefore, the unexpected ingredient/s (i.e., water, binder/s) must be identified as part of the modified substitute product name. This policy described herein is intended to serve as interim policy while the appropriate regulatory actions related to standards modernization are developed by the Food Standards and Ingredients Branch, Product Assessment Division. In this regard, the conditions and requirements described in this issuance may change as a result of the public notice and comment rulemaking process. This policy permits the use of approved, safe and suitable ingredients for fat replacement. The need for a Partial Quality Control (PQC) program is consistent with the Departments policy regarding percentage labeling. This policy memo provides further guidance for compliance with Section 317.2(b). Policy Memo 121B does not apply to breakfast sausage, cooked sausage, or fermented sausages which are addressed in PM123.

To: Branch Chiefs Food Labeling Division Product Assessment Division From: Ashland L. Clemons, Director Food Labeling Division Regulatory Programs Subject: Meat Content Requirements for Meat Soups

Policy Memo 122 August 11, 1992

ISSUE: What are the meat content requirements for meat soups? POLICY: This Policy Memo reflects a change to the current policy (outlined in the Standards and Labeling Policy Book) for condensed and ready-to-eat soups containing unsmoked meat. This policy has been changed to require a minimum of 4 percent cooked meat in condensed meat soups and 2 percent cooked meat in readyto-eat meat soups. The policy outlined in the Standards and Labeling Policy Book regarding soups containing smoked meats remains the same, viz., condensed and ready-to-eat meat soups containing smoked meats must contain a minimum of 4 percent and 2 percent smoked meat, respectively. Also, the policy regarding meat soups containing cooked sausage remains unchanged; soups made with cooked sausage shall contain at least 4 percent cooked sausage. RATIONALE: The policy on meat soups is being revised to require a minimum of 4 percent cooked meat for condensed meat soups and 2 percent cooked meat for ready-to-eat meat soups. This change is consistent with requirements for soups containing smoked meat soups. The change is supported by consumer research findings that consumers could not differentiate between a meat soup with a proposed 4 percent cooked beef content and the one meeting the current minimum beef content requirement. Also, results of consumer research indicate that consumers would consider condensed meat soups formulated with 4 percent cooked meat as being meat soups. Therefore, the Agency concludes that consumers would not be confused nor misled if meat soups, as they are currently labeled, were formulated with minimum meat contents to mirror the current minimum requirements for poultry meat soups (9 CFR 381.167).

To: Branch Chiefs

Policy Memo 123 January 20, 1995

From: Cheryl Wade, Director Food Labeling Division, RP Subject: Modified Breakfast Sausage, Cooked Sausage, and Fermented Sausage Products Identified by a Nutrient Content Claim and a Standardized or Traditional Name ISSUE: Modified breakfast sausage, cooked sausage, and fermented sausage products are substitute versions of the standardized or traditional products that have been formulated and processed to reduce the fat contents to qualify for use of nutrient content claims, but do not comply with the standard of identity or composition as described in the meat and poultry regulations or the Standards and Labeling Policy Book (Policy Book) because of the use of ingredients used for fat replacement which are precluded or restricted by these standards. The deviation from the standard or the traditional, i.e., "regular product," is conveyed by associating an expressed nutrient content claim for the appropriate reduction in fat content and the standardized or traditional product name, e.g., "Reduced Fat Frankfurter" or "Low Fat Pepperoni." The nutrient content claims that may be used are those related to a reduction in fat contents that are identified in the regulations for meat products in 9 CFR Part 317 and for poultry products in 9 CFR Part 381. Maintaining Product Integrity: The following guidelines must be applied to assure that the modified versions of the subject meat and poultry sausage products do not violate the integrity of the standardized or traditional product for which they purport to be substitutes: (1) the product must be similar in shape, flavor, consistency, and general appearance to the product as prepared according to the regulatory or traditional standard, (2) the meat or poultry used to formulate the modified product must come from the same anatomical location when the standardized term is related to an anatomical region on an animal, e.g., "ham" is expected to be from the hind leg of the hog and cured; thus, "lean smoked ham sausage" would be comprised of meat from the hind leg of a hog that has been smoked and cured, (3) the modified sausage product must result from the same processing procedures as those specified for the subject sausage products described by regulatory or Policy Book standards, (4) there must not be deviations from product safety criteria (e.g., salt content, curing agents, pH, water activity and/or moisture/protein ratio) that are provided in the regulatory or Policy Book standards for sausages, and (5) the modified product must achieve the appropriate reduction in fat content to be eligible to use a nutrient content claim in conjunction with the standardized or traditional product name. Performance Characteristics: In producing modified, substitute versions of sausages, the deviations from ingredient provisions of the regulatory and Policy Book standards should be the minimum necessary to qualify for the nutrient content claim while maintaining the performance characteristics similar to the standardized or traditional product, i.e., similar preparation, cooking, and handling characteristics. If a modified version of the standardized or traditional sausage does not perform in substantially the same way as the standardized or traditional item, the label must include a prominent statement informing the consumer of such differences. For example, a "low fat frankfurter" that essentially has all of the characteristics of a frankfurter, but cannot be grilled, would indicate "not recommended for grilling." A "reduced fat pepperoni" that displays essentially all the characteristics of pepperoni, but cannot be cooked, would, for example, indicate "not recommended for cooking" or "do not cook."

Safe and Suitable Ingredients: A modified, substitute sausage product must be formulated with approved safe and suitable ingredients, e.g., those identified in 9 CFR 318.7(c)(4) and 381.147(f)(4), and those determined to be safe and suitable by the Food Standards and Ingredients Branch, Product Assessment Division. Such ingredients are to be used at the lowest level necessary to achieve the intended effect of reducing fat as compared to the standardized or traditional product. Safe and suitable ingredients are those used to replace fat, improve texture, and prevent syneresis. An ingredient or component of an ingredient that is specifically required by the regulatory or Policy Book standard for characterizing purposes, e.g., cheese in a cheesefurter, fresh livers in liver sausage, cured ham in a ham sausage, and fennel or anise in an Italian sausage, shall be present in the required amount, if applicable, or otherwise in a significant amount to provide a characterizing identity to the product. Moreover, an ingredient or component of an ingredient that is not permitted by regulations for use in any meat or poultry sausage product, e.g., sodium benzoate, shall not be added to a modified, substitute product. Product Identity: The name of the modified version of the standardized or traditional product that complies with all parts of the policy prescribed herein is the appropriate expressed nutrient content claim for the meat and/or poultry product with a reduction in fat content and the applicable standardized or traditional term, e.g., "Lean Sausage," "97% Fat-Free (or "Low Fat") Kielbasa," "Low-Fat Frankfurter Made with Beef, Pork and Turkey," "Reduced Fat Pepperoni," "Extra Lean Turkey Italian Sausage," and "Lite Genoa Salami." The size and style of type must conform to the nutrition labeling regulations. Ingredients Statement: To assist the consumer in differentiating between the standardized or traditional sausage product and the modified, substitute version, ingredients that are not provided for by regulatory or Policy Book standards, or used in excess of the allowable levels specified, must be appropriately identified with an asterisk in the ingredients statement. The statement(s) defining the asterisk(s), e.g., "*Ingredient(s) not in regular " (fill in name of the standardized or traditional product), or "*Ingredients(s) in excess of amount permitted in regular " (fill in name of the standardized or traditional product), or both as appropriate, must be legible and conspicuous, and shall immediately follow the ingredients statement in the same size and style of type. RATIONALE: Nutrition labeling regulations that became effective on August 8, 1994, require mandatory nutrition labeling of most processed meat and poultry products, and allow for expressed nutrient content claims, among them, claims for meat and poultry products with a reduction in fat contents. The policy outlined herein provides for the use of the nutrient content claims associated with reductions in fat contents to be used in conjunction with standardized or traditional terms for breakfast sausage, cooked sausage, and fermented sausage products provided that the consumer is informed of deviations from the standard or traditional product in the ingredients statement. The policy is in harmony with FDA regulation, viz., 21 CFR 130.10, effective May 8, 1994, which provides for linking nutrient content claims and standardized names for FDA-regulated foods. This policy will safeguard the integrity of standardized and traditional foods that have served the market well while providing for substitute products that are labeled in a non-pejorative manner which will inform consumers about the differences between the standardized or traditional product and the modified, substitute product. The policy identifies conditions which must be met for the labeling of the modified versions of the subject sausage products, thereby allowing manufacturers the flexibility to develop and market sausage products with a reduction in fat contents. The policy also provides for labeling that informs the consumer of the performance characteristics of the products when they are different from those of the standardized of traditional product.

Todays consumers are demanding improved nutritional profiles of familiar foods. Because of advances in ingredient and processing technologies, processors are now able to formulate new foods that are acceptable substitutes for traditional products. The policy described herein is intended to serve as interim policy while the appropriate regulatory actions related to standards modernization are developed. In this regard, the conditions and requirements described in this issuance may change as a result of the rulemaking process. This policy reflects the Agencys commitment to modernizing meat and poultry standards. The Food Standards and Ingredients Branch, Product Assessment Division, has initiated steps toward this goal through the development of policy outlined in this issuance. The policy allows the use of approved safe and suitable ingredients to replace fat in standardized and traditional foods which should facilitate the development of lower fat, modified versions of standardized and traditional meat and poultry products. These modified products are intended to assist consumers in meeting the nutritional goal of reducing fat in their diets and are, therefore, not regarded as nutritionally inferior. This policy memo does not address modified, substitute versions of fresh (species) sausage, ground beef, or hamburger product containing added ingredients used to replace fat that qualify for use of certain nutrient content claims used in conjunction with descriptive labeling, e.g., Lean Ground Beef With a X% solution of ..., Low Fat Pork Sausage, Water and Carrageenan Product which are addressed in PM121B. Also, this policy memo is not intended to replace Policy memo 069, Labeling for Substitute Products, which allows for less than the required amounts of meat and/or poultry contents provided that information is conspicuously identified as part of the product name.

To: Branch Chiefs

Policy Memo 124 January 17, 1995

From: Cheryl Wade, Director Food Labeling Division, RP Subject: Declaration of Net Quantity of Contents on Combination Packages Containing Liquid and Solid Products ISSUE: What are the Net Contents Labeling Requirements for Combination Packages which Contain Both Liquid and Solid Products? Definition: Combination Package - A combination package is a package intended for retail sale, containing two or more individual packages or units of dissimilar commodities (for example, a lunch pack that contains a fruit drink, meat, cheese, crackers and cookies). POLICY: The guidelines for stating the net quantity of contents on combination packages containing both liquid and solid products are as follows: 1. The declaration of net quantity of contents for a combination package shall be expressed in terms of fluid measure for individual products that are liquid and in terms of avoirdupois weight for individual products that are solid, semisolid, or viscous, provided the quantity statements for identical packages or units are combined. For example, the fruit drink would be expressed in fluid measure and the meat, cheese, crackers, and cookies would be expressed in the combined avoirdupois weight. 2. The declaration of quantity shall be preceded by one of the following terms, as appropriate: "Net Weight," "Net Wt.," or "Net Contents." - The net quantity of contents declaration may appear in more than one line. Therefore, both stacked and sideby-side declarations would be considered appropriate. - Descriptive terms may be used to identify the liquid and solid components of the package, e.g., entree, meal, or drink; however, such terms shall not include brand names. - Connecting words such as "and" or "plus" are permitted to be used as part of the declaration of contents. Examples of acceptable net content declarations are as follows: (1) Entree Net Wt. 8 oz, Drink 4 fl oz (120ml) (2) Net Contents: lunch 8 oz plus fruit drink 4 fl oz (3) Net Wt. 8 oz Drink 4 fl oz (120ml) (4) Net Weight 8 oz. and 4 fl oz.

Federally inspected meat and poultry products are exempt from the requirements of the Fair Packaging and Labeling Act (FPLA), including the mandatory metric labeling provisions that went into effect February 14, 1994. However, if metric labeling is included voluntarily, such labeling should comply with the FPLA. The guidelines contained in this policy memo will be subject to the provisions prescribed in 9 CFR 317.2(h) and 381.121 of the Federal regulations. RATIONALE: As prescribed by the regulations in 9 CFR 317.2(h) and 381.121, the declaration of net quantity of contents shall be expressed in terms of fluid measure for products that are liquid, or in terms of weight for products that are solid, semisolid viscous, or a mixture of solid and liquid. However, the Federal Meat and Poultry Inspection Regulations do not address the declaration of net quantity of contents for combination products. Traditionally, FSIS has permitted companies to declare the net quantity of contents for combination packages which contained both liquid and solid products to be expressed only in terms of avoirdupois weight without declaring the fluid measure separately. Recently, the National Institute of Standards and Technology (NIST) informed FSIS that our practices were not consistent with the Uniform Packaging and Labeling Regulation prescribed in the NIST Handbook 130, which requires the declaration of both fluid and weight measures on packages containing liquid and solid products. NIST contended that such requirements are necessary to provide more accurate and adequate labeling information as to the identity and quantity of contents to facilitate price and quantity comparisons by consumers. Also, it was reported that some federally inspected products were retained by State officials because they believed that the products were mislabeled since the net content declarations did not comply with the provisions stated in the NIST Handbook 130. As a result of these occurrences, industry requested that FSIS provide regulatory guidance for the declaration of net quantity of contents for combination products. FSIS determined that the petition had merit and should be addressed through rulemaking. The policy described herein is intended to serve as interim policy while regulatory actions are being developed and is consistent with the Uniform Packaging and Labeling Regulation. Consequently, the guidelines described in this issuance may change as a result of the rulemaking process.